A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients (PARALLAX)

October 7, 2021 updated by: Novartis Pharmaceuticals

A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Study Overview

Status

Completed

Conditions

Heart Failure With Preserved Ejection Fraction

Intervention / Treatment

Detailed Description

This study was a 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate sacubitril/valsartan compared to individualized medical therapy on NT proBNP, exercise capacity, symptoms and QoL in patients with heart failure and preserved left ventricular ejection (HFpEF) fraction (LVEF > 40%). Patients were initially stratified into one of three strata according to prior treatment for comorbidities: Angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or no prior renin angiotensin system inhibitors (RASi). Patients in each stratum were randomized in a 1:1 ratio and received either sacubitril/valsartan or comparator (i.e.

enalapril for patients in ACEi strata, valsartan for patients in the ARB strata and placebo for patients in the No RASi strata). There was no designated proportion of patients planned in each stratum; the strata were populated based upon the patient's prior treatment regimen. The study consisted of a screening epoch of up to 2 weeks and a randomized treatment epoch of 24 weeks, which included a 1 to 4 week study drug up-titration epoch followed by a 20 to 23 week maintenance epoch. Uptitration to target doses was recommended to occur within the first four weeks of the study, and was performed by Investigator's discretion based on the patient's clinical status.

Study Type

Interventional

Enrollment (Actual)

2572

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1430EGF
    - Novartis Investigative Site
  - Cordoba, Argentina, X5000
    - Novartis Investigative Site
  - Cordoba, Argentina, X5004BAL
    - Novartis Investigative Site
  - Cordoba, Argentina, X5006CBI
    - Novartis Investigative Site
  - Cordoba, Argentina, X5000AAW
    - Novartis Investigative Site
  - Cordoba, Argentina, X5000EVQ
    - Novartis Investigative Site
  - Formosa, Argentina, P3600
    - Novartis Investigative Site
  - San Luis, Argentina, D5702JRS
    - Novartis Investigative Site
  - Santa Fe, Argentina, 3080
    - Novartis Investigative Site
  - Santa Fe, Argentina, S2200
    - Novartis Investigative Site
  - Santa Fe, Argentina, S3000FWO
    - Novartis Investigative Site
- Buenos Aires
  - Caba, Buenos Aires, Argentina, C1280AEB
    - Novartis Investigative Site
  - Quilmes, Buenos Aires, Argentina, B1878GEG
    - Novartis Investigative Site
- Misiones
  - Posadas, Misiones, Argentina, N3300AHX
    - Novartis Investigative Site
- Provincia De Salta
  - Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
    - Novartis Investigative Site
- San Miguel De Tucuman
  - Tucuman, San Miguel De Tucuman, Argentina, T4000ICL
    - Novartis Investigative Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DSV
    - Novartis Investigative Site
- Tucuman
  - San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
    - Novartis Investigative Site
Austria
- - Braunau, Austria, A5280
    - Novartis Investigative Site
  - Graz, Austria, A-8036
    - Novartis Investigative Site
  - Hall in Tirol, Austria, 6060
    - Novartis Investigative Site
  - Linz, Austria, 4010
    - Novartis Investigative Site
  - Salzburg, Austria, 5020
    - Novartis Investigative Site
Belgium
- - Genk, Belgium, 3600
    - Novartis Investigative Site
  - Gent, Belgium, 9000
    - Novartis Investigative Site
  - Heusden-Zolder, Belgium, 3550
    - Novartis Investigative Site
  - Huy, Belgium, 4500
    - Novartis Investigative Site
  - Kortrijk, Belgium, 8500
    - Novartis Investigative Site
Brazil
- CE
  - Fortaleza, CE, Brazil, 60430 370
    - Novartis Investigative Site
- GO
  - Goiania, GO, Brazil, 74605 050
    - Novartis Investigative Site
  - Goiania, GO, Brazil, 74223-130
    - Novartis Investigative Site
- MG
  - Belo Horizonte, MG, Brazil, 30140 062
    - Novartis Investigative Site
  - Belo Horizonte, MG, Brazil, 30150-221
    - Novartis Investigative Site
- Parana
  - Curitiba, Parana, Brazil, 80230 130
    - Novartis Investigative Site
- RS
  - Porto Alegre, RS, Brazil, 90880-480
    - Novartis Investigative Site
- Rio Grande Do Sul
  - Canoas, Rio Grande Do Sul, Brazil, 92425 900
    - Novartis Investigative Site
- SC
  - Blumenau, SC, Brazil, 89010 500
    - Novartis Investigative Site
- SP
  - Campinas, SP, Brazil, 13060 080
    - Novartis Investigative Site
  - Ribeirao Preto, SP, Brazil, 14048-900
    - Novartis Investigative Site
  - Sao Jose do Rio Preto, SP, Brazil, 15015-750
    - Novartis Investigative Site
  - Sao Jose do Rio Preto, SP, Brazil, 15090-000
    - Novartis Investigative Site
Bulgaria
- - Burgas, Bulgaria, 8018
    - Novartis Investigative Site
  - Pazardzhik, Bulgaria, 4400
    - Novartis Investigative Site
  - Pernik, Bulgaria, 2300
    - Novartis Investigative Site
  - Pleven, Bulgaria, 5800
    - Novartis Investigative Site
  - Plovdiv, Bulgaria, 4002
    - Novartis Investigative Site
  - Plovdiv, Bulgaria, 4000
    - Novartis Investigative Site
  - Shumen, Bulgaria, 9700
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1527
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1431
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1233
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1606
    - Novartis Investigative Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Novartis Investigative Site
Canada
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - Novartis Investigative Site
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - Novartis Investigative Site
  - Oakville, Ontario, Canada, L6K 3W7
    - Novartis Investigative Site
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - Novartis Investigative Site
  - St-Georges Beauce, Quebec, Canada, G5Y 4T8
    - Novartis Investigative Site
Colombia
- - Barranquilla, Colombia
    - Novartis Investigative Site
  - Barranquilla, Colombia, 080020
    - Novartis Investigative Site
  - Monteria, Colombia
    - Novartis Investigative Site
  - San Gil, Colombia, 684031
    - Novartis Investigative Site
- Antioquia
  - Medellin, Antioquia, Colombia, 050036
    - Novartis Investigative Site
- Valle Del Cauca
  - Cali, Valle Del Cauca, Colombia, 760001
    - Novartis Investigative Site
Czechia
- - Kolin, Czechia, 280 20
    - Novartis Investigative Site
  - Olomouc Lazce, Czechia, 77900
    - Novartis Investigative Site
  - Prerov, Czechia, 751 52
    - Novartis Investigative Site
  - Valasske Mezirici, Czechia, 75742
    - Novartis Investigative Site
- CZE
  - JIhlava, CZE, Czechia, 58633
    - Novartis Investigative Site
  - Policska, CZE, Czechia, 57201
    - Novartis Investigative Site
- Czech Republic
  - Brandys nad Labem, Czech Republic, Czechia, 250 01
    - Novartis Investigative Site
  - Brno, Czech Republic, Czechia, 60200
    - Novartis Investigative Site
  - Cesky Krumlov, Czech Republic, Czechia, 381 01
    - Novartis Investigative Site
  - Jablonec nad Nisou, Czech Republic, Czechia, 466 60
    - Novartis Investigative Site
  - Kromeriz, Czech Republic, Czechia, 767 55
    - Novartis Investigative Site
  - Liberec, Czech Republic, Czechia, 46063
    - Novartis Investigative Site
  - Louny, Czech Republic, Czechia
    - Novartis Investigative Site
  - Pardubice, Czech Republic, Czechia, 532 03
    - Novartis Investigative Site
  - Plzen, Czech Republic, Czechia, 30100
    - Novartis Investigative Site
  - Svitavy, Czech Republic, Czechia, 568 25
    - Novartis Investigative Site
  - Tabor, Czech Republic, Czechia, 39003
    - Novartis Investigative Site
  - Trebic, Czech Republic, Czechia, 674 01
    - Novartis Investigative Site
Denmark
- - Copenhagen NV, Denmark, DK-2400
    - Novartis Investigative Site
  - Hvidovre, Denmark, 2650
    - Novartis Investigative Site
  - Randers, Denmark, 8930
    - Novartis Investigative Site
Estonia
- - Tallinn, Estonia, 13419
    - Novartis Investigative Site
  - Tallinn, Estonia, 10138
    - Novartis Investigative Site
  - Tartu, Estonia, 51014
    - Novartis Investigative Site
France
- - Besancon cedex, France, 25030
    - Novartis Investigative Site
  - Chambray les Tours, France, 37170
    - Novartis Investigative Site
  - Corbeil Essonnes, France, 91100
    - Novartis Investigative Site
  - Le Coudray, France, 28630
    - Novartis Investigative Site
  - Le Kremlin Bicetre, France, 94275
    - Novartis Investigative Site
  - Limoges cedex, France, 87042
    - Novartis Investigative Site
  - Marseille, France, 13008
    - Novartis Investigative Site
  - Rennes Cedex 9, France, 35033
    - Novartis Investigative Site
  - Tourcoing, France, 59200
    - Novartis Investigative Site
  - Valenciennes, France, 59300
    - Novartis Investigative Site
Germany
- - Bad Homburg, Germany, 61348
    - Novartis Investigative Site
  - Bad Oeynhausen, Germany, 32545
    - Novartis Investigative Site
  - Bamberg, Germany, 96049
    - Novartis Investigative Site
  - Berlin, Germany, 13353
    - Novartis Investigative Site
  - Berlin, Germany, 10787
    - Novartis Investigative Site
  - Berlin, Germany, 10789
    - Novartis Investigative Site
  - Berlin, Germany, 12157
    - Novartis Investigative Site
  - Berlin, Germany, 12683
    - Novartis Investigative Site
  - Berlin, Germany, 13347
    - Novartis Investigative Site
  - Berlin, Germany, D 10559
    - Novartis Investigative Site
  - Berlin Buch, Germany, 13125
    - Novartis Investigative Site
  - Bielefeld, Germany, 33604
    - Novartis Investigative Site
  - Bochum Wattenscheid, Germany, 44866
    - Novartis Investigative Site
  - Brueel, Germany, 19412
    - Novartis Investigative Site
  - Chemnitz, Germany, 09130
    - Novartis Investigative Site
  - Coburg, Germany, 96450
    - Novartis Investigative Site
  - Dortmund, Germany, 44137
    - Novartis Investigative Site
  - Dortmund, Germany, 44379
    - Novartis Investigative Site
  - Dresden, Germany, 01307
    - Novartis Investigative Site
  - Dresden, Germany, 01277
    - Novartis Investigative Site
  - Dresden, Germany, 01069
    - Novartis Investigative Site
  - Elsterwerda, Germany, 04910
    - Novartis Investigative Site
  - Erfurt, Germany, 99097
    - Novartis Investigative Site
  - Essen, Germany, 45277
    - Novartis Investigative Site
  - Frankfurt, Germany, 60594
    - Novartis Investigative Site
  - Frankfurt, Germany, 65929
    - Novartis Investigative Site
  - Fuerth, Germany, 90766
    - Novartis Investigative Site
  - Fulda, Germany, 36037
    - Novartis Investigative Site
  - Halle Saale, Germany, 06120
    - Novartis Investigative Site
  - Hamburg, Germany, 21075
    - Novartis Investigative Site
  - Hassloch, Germany, 67454
    - Novartis Investigative Site
  - Jena, Germany, 07740
    - Novartis Investigative Site
  - Kiel, Germany, 24105
    - Novartis Investigative Site
  - Koeln-Nippes, Germany, 50733
    - Novartis Investigative Site
  - Koln, Germany, D-51065
    - Novartis Investigative Site
  - Leipzig, Germany, 04103
    - Novartis Investigative Site
  - Lubeck, Germany, 23538
    - Novartis Investigative Site
  - Ludwigshafen, Germany, 67067
    - Novartis Investigative Site
  - Ludwigshafen, Germany, 67071
    - Novartis Investigative Site
  - Lüneburg, Germany, 21339
    - Novartis Investigative Site
  - Mainz, Germany, 55116
    - Novartis Investigative Site
  - Mannheim, Germany, 68165
    - Novartis Investigative Site
  - Muehldorf, Germany, 84453
    - Novartis Investigative Site
  - Muenster, Germany, 48149
    - Novartis Investigative Site
  - Munich, Germany, 80638
    - Novartis Investigative Site
  - Neuruppin, Germany, 16816
    - Novartis Investigative Site
  - Nienburg, Germany, 31582
    - Novartis Investigative Site
  - Nuremberg, Germany, 90402
    - Novartis Investigative Site
  - Papenburg, Germany, 26871
    - Novartis Investigative Site
  - Potsdam, Germany, 14471
    - Novartis Investigative Site
  - Riesa, Germany, 01589
    - Novartis Investigative Site
  - Rodgau, Germany, 63110
    - Novartis Investigative Site
  - Rostock, Germany, 18107
    - Novartis Investigative Site
  - Rotenburg an der Fulda, Germany, 36199
    - Novartis Investigative Site
  - Ruesselsheim, Germany, 65428
    - Novartis Investigative Site
  - Schwaebisch Hall, Germany, 74523
    - Novartis Investigative Site
  - Siegen, Germany, 57072
    - Novartis Investigative Site
  - Stadtlohn, Germany, 48703
    - Novartis Investigative Site
  - Ulm, Germany, 89081
    - Novartis Investigative Site
  - Ulm, Germany, 89077
    - Novartis Investigative Site
  - Wallerfing, Germany, 94574
    - Novartis Investigative Site
  - Wedel, Germany, 22880
    - Novartis Investigative Site
  - Wismar, Germany, 23966
    - Novartis Investigative Site
  - Wuerzburg, Germany, 97080
    - Novartis Investigative Site
- Bavaria
  - Regensburg, Bavaria, Germany, 93053
    - Novartis Investigative Site
- DEU
  - Essen, DEU, Germany, 45138
    - Novartis Investigative Site
- NRW
  - Detmold, NRW, Germany, 32756
    - Novartis Investigative Site
- Sachsen
  - Dresden, Sachsen, Germany, 01099
    - Novartis Investigative Site
Guatemala
- - Guatemala, Guatemala, 01010
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01010
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01001
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01011
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01015
    - Novartis Investigative Site
Hungary
- - Budapest, Hungary, 1085
    - Novartis Investigative Site
  - Budapest, Hungary, 1134
    - Novartis Investigative Site
  - Mosanmagyarovar, Hungary, 9200
    - Novartis Investigative Site
  - Szeged, Hungary, 6720
    - Novartis Investigative Site
- HUN
  - Budapest, HUN, Hungary, 1145
    - Novartis Investigative Site
India
- - India, India, 560040
    - Novartis Investigative Site
- Delhi
  - New Delhi, Delhi, India, 110 060
    - Novartis Investigative Site
  - New Delhi, Delhi, India, 110007
    - Novartis Investigative Site
- Gujarat
  - Ahmedabad, Gujarat, India, 380 060
    - Novartis Investigative Site
  - Vadodara, Gujarat, India, 390022
    - Novartis Investigative Site
- Karnataka
  - Manipal, Karnataka, India, 576104
    - Novartis Investigative Site
- Maharashtra
  - Nagpur, Maharashtra, India, 440009
    - Novartis Investigative Site
  - Nashik, Maharashtra, India, 422005
    - Novartis Investigative Site
- Maharastra
  - Nashik, Maharastra, India, 422007
    - Novartis Investigative Site
- Rajasthan
  - Bikaner, Rajasthan, India, 334003
    - Novartis Investigative Site
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226003
    - Novartis Investigative Site
Israel
- - Ashkelon, Israel, 78278
    - Novartis Investigative Site
  - Be'er Sheva, Israel, 84101
    - Novartis Investigative Site
  - Hadera, Israel
    - Novartis Investigative Site
  - Haifa, Israel, 310 9601
    - Novartis Investigative Site
  - Petach Tikva, Israel, 4941492
    - Novartis Investigative Site
  - Rehovot, Israel, 76100
    - Novartis Investigative Site
Italy
- - Cona, Italy
    - Novartis Investigative Site
  - San Vito al Tagliamento, Italy
    - Novartis Investigative Site
- AR
  - Cortona, AR, Italy, 52044
    - Novartis Investigative Site
- BG
  - Bergamo, BG, Italy, 24127
    - Novartis Investigative Site
- BO
  - Bologna, BO, Italy, 40138
    - Novartis Investigative Site
- MI
  - Legnano, MI, Italy, 20025
    - Novartis Investigative Site
  - Milano, MI, Italy, 20162
    - Novartis Investigative Site
  - Milano, MI, Italy, 20132
    - Novartis Investigative Site
  - Sesto San Giovanni, MI, Italy, 20099
    - Novartis Investigative Site
- PA
  - Palermo, PA, Italy, 90127
    - Novartis Investigative Site
- RO
  - Rovigo, RO, Italy, 45100
    - Novartis Investigative Site
- SS
  - Sassari, SS, Italy, 07100
    - Novartis Investigative Site
Latvia
- - Daugavpils, Latvia, LV-5417
    - Novartis Investigative Site
  - Ogre, Latvia, 5001
    - Novartis Investigative Site
  - Riga, Latvia, 1012
    - Novartis Investigative Site
- LVA
  - Liepaja, LVA, Latvia, 3401
    - Novartis Investigative Site
Lithuania
- - Kaunas, Lithuania, 47144
    - Novartis Investigative Site
  - Vilnius, Lithuania, LT-08661
    - Novartis Investigative Site
- LTU
  - Kaunas, LTU, Lithuania, LT 50161
    - Novartis Investigative Site
Mexico
- - Queretaro, Mexico, 76000
    - Novartis Investigative Site
  - San Luis Potosi, Mexico, 78200
    - Novartis Investigative Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
    - Novartis Investigative Site
  - Guadalajara, Jalisco, Mexico, 44200
    - Novartis Investigative Site
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Novartis Investigative Site
  - Amsterdam, Netherlands, 1091AC
    - Novartis Investigative Site
  - Deventer, Netherlands, 7416 SE
    - Novartis Investigative Site
  - Doetinchem, Netherlands, 7009 BL
    - Novartis Investigative Site
  - Gouda, Netherlands, 2803 HH
    - Novartis Investigative Site
  - Groningen, Netherlands, 9713 GZ
    - Novartis Investigative Site
  - Hardenberg, Netherlands, 7770 AA
    - Novartis Investigative Site
  - Nijmegen, Netherlands, 6500 HB
    - Novartis Investigative Site
  - Stadskanaal, Netherlands, 9501 HE
    - Novartis Investigative Site
  - Tilburg, Netherlands, 5022 GC
    - Novartis Investigative Site
  - Venlo, Netherlands, 5912 BL
    - Novartis Investigative Site
Peru
- - Callao, Peru, Callao 2
    - Novartis Investigative Site
- La Libertad
  - Trujillo, La Libertad, Peru
    - Novartis Investigative Site
- Lima
  - Cercado De Lima, Lima, Peru, 01
    - Novartis Investigative Site
  - Jesus Maria, Lima, Peru, 11
    - Novartis Investigative Site
  - San Borja, Lima, Peru, 41
    - Novartis Investigative Site
  - San Isidro, Lima, Peru, 27
    - Novartis Investigative Site
  - San Miguel, Lima, Peru, 32
    - Novartis Investigative Site
Portugal
- - Braga, Portugal, 4710243
    - Novartis Investigative Site
  - Lisboa, Portugal, 1495 005
    - Novartis Investigative Site
  - Lisboa, Portugal, 1500 650
    - Novartis Investigative Site
  - Lisboa, Portugal, 1600190
    - Novartis Investigative Site
  - Penafiel, Portugal, 4564-007
    - Novartis Investigative Site
  - Porto, Portugal, 4099-001
    - Novartis Investigative Site
  - Viana do Castelo, Portugal, 4901858
    - Novartis Investigative Site
  - Vila Real, Portugal, 5000-508
    - Novartis Investigative Site
Romania
- - Bacau, Romania, 600114
    - Novartis Investigative Site
  - Baia Mare, Romania, 430123
    - Novartis Investigative Site
  - Bucharest, Romania, 021659
    - Novartis Investigative Site
  - Bucuresti, Romania, 022328
    - Novartis Investigative Site
  - Bucuresti, Romania, 062272
    - Novartis Investigative Site
  - Craiova, Romania, 200642
    - Novartis Investigative Site
  - Craiova, Romania, 200931
    - Novartis Investigative Site
  - Pitesti, Romania, 110084
    - Novartis Investigative Site
  - Targu Mures, Romania, 540142
    - Novartis Investigative Site
  - Targu Mures, Romania, 540143
    - Novartis Investigative Site
  - Timisoara, Romania, 300736
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  - Tirgoviste, Romania, 130095
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- District 4
  - Bucuresti, District 4, Romania, 4204179
    - Novartis Investigative Site
- Timis
  - Timisoara, Timis, Romania, 300362
    - Novartis Investigative Site
  - Timisoara, Timis, Romania, 300041
    - Novartis Investigative Site
Russian Federation
- - Ekaterinburg, Russian Federation, 620028
    - Novartis Investigative Site
  - Gatchina, Russian Federation, 188300
    - Novartis Investigative Site
  - Ivanovo, Russian Federation, 153012
    - Novartis Investigative Site
  - Moscow, Russian Federation, 117292
    - Novartis Investigative Site
  - Moscow, Russian Federation, 101953
    - Novartis Investigative Site
  - Moscow, Russian Federation, 117556
    - Novartis Investigative Site
  - Moscow, Russian Federation, 121309
    - Novartis Investigative Site
  - Moscow, Russian Federation, 129301
    - Novartis Investigative Site
  - Nizhnii Novgorod, Russian Federation, 603126
    - Novartis Investigative Site
  - Perm, Russian Federation, 614097
    - Novartis Investigative Site
  - Rostov on Don, Russian Federation, 344022
    - Novartis Investigative Site
  - Rostov on Don, Russian Federation, 344068
    - Novartis Investigative Site
  - Saint Petersburg, Russian Federation, 199106
    - Novartis Investigative Site
  - Saint-Petersburg, Russian Federation, 191144
    - Novartis Investigative Site
  - Saratov, Russian Federation, 410012
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 196601
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 191015
    - Novartis Investigative Site
  - St Petersburg, Russian Federation, 197376
    - Novartis Investigative Site
  - Tyumen, Russian Federation, 625026
    - Novartis Investigative Site
  - Yaroslavl, Russian Federation, 150047
    - Novartis Investigative Site
  - Yekaterinburg, Russian Federation, 620109
    - Novartis Investigative Site
Serbia
- - Belgrade, Serbia, 11 000
    - Novartis Investigative Site
  - Kragujevac, Serbia, 34000
    - Novartis Investigative Site
  - Nis, Serbia, 18000
    - Novartis Investigative Site
  - Niska Banja, Serbia, 18205
    - Novartis Investigative Site
  - Sremska Kamenica, Serbia, 21204
    - Novartis Investigative Site
Slovakia
- - Bardejov, Slovakia, 085 01
    - Novartis Investigative Site
  - Bardejov, Slovakia, 08501
    - Novartis Investigative Site
  - Bratislava, Slovakia, 821 07
    - Novartis Investigative Site
  - Bratislava, Slovakia, 842 31
    - Novartis Investigative Site
  - Dolny Kubin, Slovakia, 026 01
    - Novartis Investigative Site
  - Kosice, Slovakia, 040 01
    - Novartis Investigative Site
  - Lucenec, Slovakia, 98439
    - Novartis Investigative Site
  - Moldava nad Bodvou, Slovakia, 045 01
    - Novartis Investigative Site
  - Nitra, Slovakia, 949 01
    - Novartis Investigative Site
  - Nove Zamky, Slovakia, 940 01
    - Novartis Investigative Site
  - Nove Zamky, Slovakia, 94002
    - Novartis Investigative Site
  - Povazska Bystrica, Slovakia, 01701
    - Novartis Investigative Site
  - Presov, Slovakia, 08001
    - Novartis Investigative Site
  - Snina, Slovakia, 09601
    - Novartis Investigative Site
  - Svidnik, Slovakia, 089 01
    - Novartis Investigative Site
  - Trnava, Slovakia, 91701
    - Novartis Investigative Site
- SVK
  - Bratislava, SVK, Slovakia, 81108
    - Novartis Investigative Site
  - Handlova, SVK, Slovakia, 97251
    - Novartis Investigative Site
- Slovak Republic
  - Namestovo, Slovak Republic, Slovakia, 02901
    - Novartis Investigative Site
  - Presov, Slovak Republic, Slovakia, 080 01
    - Novartis Investigative Site
Spain
- - Alicante, Spain, 03700
    - Novartis Investigative Site
  - Las Palmas De Gran Canarias, Spain, 35010
    - Novartis Investigative Site
  - Madrid, Spain, 28040
    - Novartis Investigative Site
  - Sevilla, Spain, 41014
    - Novartis Investigative Site
  - Valencia, Spain, 46026
    - Novartis Investigative Site
- Andalucia
  - Cordoba, Andalucia, Spain, 14004
    - Novartis Investigative Site
  - Huelva, Andalucia, Spain, 21005
    - Novartis Investigative Site
  - Malaga, Andalucia, Spain, 29010
    - Novartis Investigative Site
- Cadiz
  - Puerto Real, Cadiz, Spain, 11510
    - Novartis Investigative Site
  - Villamartin, Cadiz, Spain, 11650
    - Novartis Investigative Site
- Cataluna
  - Lerida, Cataluna, Spain, 25198
    - Novartis Investigative Site
- Comunidad Valenciana
  - Torrevieja (Alicante), Comunidad Valenciana, Spain, 03186
    - Novartis Investigative Site
  - Valencia, Comunidad Valenciana, Spain, 46010
    - Novartis Investigative Site
- Galicia
  - A Coruna, Galicia, Spain, 15006
    - Novartis Investigative Site
- Madrid
  - San Sebastian de los Reyes, Madrid, Spain, 28702
    - Novartis Investigative Site
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Novartis Investigative Site
- Valencia
  - Manises, Valencia, Spain, 46940
    - Novartis Investigative Site
Thailand
- - Bangkok, Thailand, 10330
    - Novartis Investigative Site
  - Bangkok, Thailand, 10700
    - Novartis Investigative Site
  - Bangkok, Thailand, 10400
    - Novartis Investigative Site
  - Muang, Thailand, 65000
    - Novartis Investigative Site
  - Ubon Ratchathani, Thailand, 34000
    - Novartis Investigative Site
- THA
  - Khon Kaen, THA, Thailand, 40002
    - Novartis Investigative Site
Turkey
- - Adana, Turkey, 01160
    - Novartis Investigative Site
  - Ankara, Turkey, 06490
    - Novartis Investigative Site
  - Antalya, Turkey, 07070
    - Novartis Investigative Site
  - Aydin, Turkey, 09100
    - Novartis Investigative Site
  - Bursa, Turkey
    - Novartis Investigative Site
  - Istanbul, Turkey, 34304
    - Novartis Investigative Site
  - Istanbul, Turkey, 34662
    - Novartis Investigative Site
  - Izmir, Turkey, 35040
    - Novartis Investigative Site
  - Izmir, Turkey, 35340
    - Novartis Investigative Site
  - Kocaeli, Turkey, 41380
    - Novartis Investigative Site
  - Mersin, Turkey, 33343
    - Novartis Investigative Site
  - Sivas, Turkey, 58140
    - Novartis Investigative Site
  - Talas / Kayseri, Turkey, 38039
    - Novartis Investigative Site
- Meselik
  - Eskisehir, Meselik, Turkey, 26480
    - Novartis Investigative Site
United Kingdom
- - Leeds, United Kingdom, LS1 3EX
    - Novartis Investigative Site
  - York, United Kingdom, YO31 8HE
    - Novartis Investigative Site
- Buckinghamshire
  - High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
    - Novartis Investigative Site
- Cleveland
  - Stockton on Tees, Cleveland, United Kingdom, TS19 8PE
    - Novartis Investigative Site
- Derbyshire
  - Chesterfield, Derbyshire, United Kingdom, S44 5BL
    - Novartis Investigative Site
- Northern Ireland
  - Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
    - Novartis Investigative Site
- Peterborough
  - Wansford, Peterborough, United Kingdom, PE8 6PL
    - Novartis Investigative Site
- Surrey
  - Addlestone, Surrey, United Kingdom, KT15 2BH
    - Novartis Investigative Site
- Tyne And Wear
  - Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
    - Novartis Investigative Site
United States
- Alabama
  - Andalusia, Alabama, United States, 36420
    - Novartis Investigative Site
  - Mobile, Alabama, United States, 36608
    - Novartis Investigative Site
- California
  - Beverly Hills, California, United States, 90211
    - Novartis Investigative Site
  - Long Beach, California, United States, 90813
    - Novartis Investigative Site
  - Santa Ana, California, United States, 92704
    - Novartis Investigative Site
  - Sylmar, California, United States, 91342
    - Novartis Investigative Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Novartis Investigative Site
- Connecticut
  - Stamford, Connecticut, United States, 06905
    - Novartis Investigative Site
- Florida
  - Bradenton, Florida, United States, 34209
    - Novartis Investigative Site
  - Gainesville, Florida, United States, 32608
    - Novartis Investigative Site
  - Hollywood, Florida, United States, 33312
    - Novartis Investigative Site
  - Miami, Florida, United States, 33133
    - Novartis Investigative Site
  - Port Orange, Florida, United States, 32127
    - Novartis Investigative Site
- Georgia
  - Thomasville, Georgia, United States, 31792
    - Novartis Investigative Site
- Illinois
  - Arlington Heights, Illinois, United States, 60004
    - Novartis Investigative Site
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Novartis Investigative Site
  - Chalmette, Louisiana, United States, 70043
    - Novartis Investigative Site
  - Houma, Louisiana, United States, 70360
    - Novartis Investigative Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Novartis Investigative Site
- Nebraska
  - Lincoln, Nebraska, United States, 68526
    - Novartis Investigative Site
  - Omaha, Nebraska, United States, 68114
    - Novartis Investigative Site
- New York
  - Rochester, New York, United States, 14621
    - Novartis Investigative Site
- Ohio
  - Marion, Ohio, United States, 43302
    - Novartis Investigative Site
- Oregon
  - Corvallis, Oregon, United States, 97330
    - Novartis Investigative Site
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Novartis Investigative Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Novartis Investigative Site
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - Novartis Investigative Site
- Texas
  - Dallas, Texas, United States, 75234
    - Novartis Investigative Site
  - Lufkin, Texas, United States, 75904
    - Novartis Investigative Site
  - Tomball, Texas, United States, 77375
    - Novartis Investigative Site
- Virginia
  - Falls Church, Virginia, United States, 22042
    - Novartis Investigative Site
- Washington
  - Seattle, Washington, United States, 98122
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch
Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
NYHA class II-IV
Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
KCCQ clinical summary score < 75
Patients on ACEi or ARB therapy must have a history of HTN

Exclusion Criteria:

Any prior measurement of LVEF ≤ 40%, under stable conditions
Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40%
Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
History of hypersensitivity to LCZ696 or its components
Patients with a known history of angioedema
Walk distance primarily limited by non-cardiac comorbid conditions at study entry
Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2.
Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry.
Patients with HbA1c > 7.5% not treated for diabetes
Patients with prior major organ transplant or intent to transplant (ie on transplant list)
eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry
History or presence of any other disease with a life expectancy of < 3 years
Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sacubitril/valsartan (LCZ696) All patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo. Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo). In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally).	Drug: sacubitril/valsartan Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally Drug: Placebo to match enalapril Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally Drug: Placebo to match valsartan Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally
Active Comparator: Comparator Patients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum). Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily). Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily). Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo.	Drug: Enalapril Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally Drug: Valsartan Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally Drug: Placebo to match sacubitril/valsartan Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

Participant Group / Arm

Intervention / Treatment

Experimental: sacubitril/valsartan (LCZ696)

All patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo.

Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo).

In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally).

Drug: sacubitril/valsartan

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

Drug: Placebo to match enalapril

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

Drug: Placebo to match valsartan

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Active Comparator: Comparator

Patients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum).

Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily).

Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily).

Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo.

Drug: Enalapril

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

Drug: Valsartan

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

Drug: Placebo to match sacubitril/valsartan

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12 Time Frame: Baseline, week 12	To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF	Baseline, week 12
Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24 Time Frame: Baseline, week 24	Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002.	Baseline, week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24 Time Frame: Baseline, Week 24	The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.	Baseline, Week 24
Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24 Time Frame: Baseline, Week 24	Percentage of patients with KCCQ CSS deterioration ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.	Baseline, Week 24
Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24 Time Frame: Baseline, Week 24	Percentage of patients with KCCQ CSS improvement ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.	Baseline, Week 24
Change From Baseline in NYHA Functional Class at Week 24 Time Frame: Baseline, week 24	NYHA classification is a subjective physician's assessment of patient's functional capacity and symptomatic status and can change frequently over time. Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF Class IV - Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest The NYHA class change will be analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively.	Baseline, week 24
Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 Time Frame: Baseline, Week 24	The SF-36 PCS score reflects the measure of quality of life based on the 36 questions which evaluate the person's physical, emotional, and mental status, including general health. Specifically, the SF-36 PCS score focuses on assessing the person's physical status. The score ranges from 0 to 100 with a higher score indicating a better status of physical wellbeing (range = 0 "worst"-100 "best").	Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

Helpful Links

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2017

Primary Completion (Actual)

October 28, 2019

Study Completion (Actual)

October 28, 2019

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CLCZ696D2302
2016-003410-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Heart Failure With Preserved Ejection Fraction

Clinical Trials on sacubitril/valsartan

Search Similar Trials

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