Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients (RELAX-AHF-EU)

December 18, 2018 updated by: Novartis Pharmaceuticals

A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

Study Overview

Status

Terminated

Conditions

Acute Heart Failure (AHF)

Intervention / Treatment

Detailed Description

This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Study Type

Interventional

Enrollment (Actual)

2666

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

Austria
- - Feldkirch, Austria, A-6807
    - Novartis Investigative Site
  - Graz, Austria, 8020
    - Novartis Investigative Site
  - Linz, Austria, A-4020
    - Novartis Investigative Site
  - Salzburg, Austria, A-5020
    - Novartis Investigative Site
  - Salzburg, Austria, 5010
    - Novartis Investigative Site
  - St. Poelten, Austria, 3100
    - Novartis Investigative Site
  - Vienna, Austria, 1130
    - Novartis Investigative Site
  - Vienna, Austria, A-1020
    - Novartis Investigative Site
  - Wien, Austria, A-1160
    - Novartis Investigative Site
Belgium
- - Aalst, Belgium, 9300
    - Novartis Investigative Site
  - Brugge, Belgium, 8000
    - Novartis Investigative Site
  - Brussel, Belgium, 1090
    - Novartis Investigative Site
  - Gent, Belgium, 9000
    - Novartis Investigative Site
  - Hasselt, Belgium, 3500
    - Novartis Investigative Site
  - Leuven, Belgium, 3000
    - Novartis Investigative Site
  - Liege, Belgium, 4000
    - Novartis Investigative Site
  - Lodelinsart, Belgium, 6042
    - Novartis Investigative Site
  - Mol, Belgium, 2400
    - Novartis Investigative Site
  - Mons, Belgium, 7000
    - Novartis Investigative Site
  - Roeselare, Belgium, 8800
    - Novartis Investigative Site
  - Ronse, Belgium, 9600
    - Novartis Investigative Site
  - Turnhout, Belgium, 2300
    - Novartis Investigative Site
Bulgaria
- - Gabrovo, Bulgaria, 5300
    - Novartis Investigative Site
  - Plovdiv, Bulgaria, 4000
    - Novartis Investigative Site
  - Ruse, Bulgaria, 7002
    - Novartis Investigative Site
  - Sliven, Bulgaria, 8800
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1431
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1233
    - Novartis Investigative Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Novartis Investigative Site
Croatia
- - Zagreb, Croatia, 10000
    - Novartis Investigative Site
- HRV
  - Varazdin, HRV, Croatia, 42000
    - Novartis Investigative Site
Czechia
- - Plzen, Czechia, 301 00
    - Novartis Investigative Site
  - Prague 5, Czechia, 150 06
    - Novartis Investigative Site
- Czech Republic
  - Brno, Czech Republic, Czechia, 656 91
    - Novartis Investigative Site
  - Decin II, Czech Republic, Czechia, 405 99
    - Novartis Investigative Site
  - Karvina-Raj, Czech Republic, Czechia, 73412
    - Novartis Investigative Site
  - Kromeriz, Czech Republic, Czechia, 767 55
    - Novartis Investigative Site
  - Melnik, Czech Republic, Czechia, 27601
    - Novartis Investigative Site
  - Pisek, Czech Republic, Czechia, 39701
    - 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
Estonia
- - Tallinn, Estonia, 13419
    - Novartis Investigative Site
  - Tartu, Estonia, 51014
    - Novartis Investigative Site
Finland
- - Turku, Finland, 20520
    - Novartis Investigative Site
France
- - Abbeville, France, 80100
    - Novartis Investigative Site
  - Agen Cedex 9, France, 47923
    - Novartis Investigative Site
  - Amiens cedex 1, France, 80054
    - Novartis Investigative Site
  - Avignon, France, 84000
    - Novartis Investigative Site
  - Belfort, France, 90 016
    - Novartis Investigative Site
  - Besancon Cedex, France, 25030
    - Novartis Investigative Site
  - Brest, France, 29200
    - Novartis Investigative Site
  - Bron, France, 69677
    - Novartis Investigative Site
  - Chalon sur Saône, France, 71321
    - Novartis Investigative Site
  - Chambray-lès-Tours, France, 37170
    - Novartis Investigative Site
  - Chateauroux, France, 36000
    - Novartis Investigative Site
  - Clermont-Ferrand, France, 63003
    - Novartis Investigative Site
  - Corbeil Essonnes, France, 91100
    - Novartis Investigative Site
  - Dunkerque, France, 59385
    - Novartis Investigative Site
  - La Seyne sur mer, France, 83500
    - Novartis Investigative Site
  - Le Coudray, France, 28630
    - Novartis Investigative Site
  - Le Mans Cedex 09, France, 72037
    - Novartis Investigative Site
  - Lens, France, 62307
    - Novartis Investigative Site
  - Limoges Cedex, France, 87042
    - Novartis Investigative Site
  - Lorient Cedex, France, 56322
    - Novartis Investigative Site
  - Metz, France, 57085
    - Novartis Investigative Site
  - Montauban, France, 82013
    - Novartis Investigative Site
  - Montauban, France, 82017
    - Novartis Investigative Site
  - Montpellier, France, 34295
    - Novartis Investigative Site
  - Mulhouse cedex, France, 68070
    - Novartis Investigative Site
  - Nimes Cedex 09, France, 30029
    - Novartis Investigative Site
  - Niort, France, 79021
    - Novartis Investigative Site
  - Orleans, France, 45100
    - Novartis Investigative Site
  - Paris, France, 75013
    - Novartis Investigative Site
  - Paris, France, 75015
    - Novartis Investigative Site
  - Paris cedex 10, France, 75010
    - Novartis Investigative Site
  - Pau, France, 64000
    - Novartis Investigative Site
  - Poitiers, France, 86021
    - Novartis Investigative Site
  - Périgueux, France, 24019
    - Novartis Investigative Site
  - Rennes Cedex 9, France, 35033
    - Novartis Investigative Site
  - Saint Brieuc, France, 22027
    - Novartis Investigative Site
  - St Michel, France, 16470
    - Novartis Investigative Site
  - St Priest en Jarez Cedex, France, 42277
    - Novartis Investigative Site
  - Strasbourg Cedex, France, 67091
    - Novartis Investigative Site
  - Troyes, France, 10003
    - Novartis Investigative Site
  - Vienne, France, 38209
    - Novartis Investigative Site
- Bouches Du Rhone
  - Marseille cedex 20, Bouches Du Rhone, France, 13915
    - Novartis Investigative Site
- Cedex
  - Nancy, Cedex, France, 54035
    - Novartis Investigative Site
Germany
- - Arnstadt, Germany, 99310
    - Novartis Investigative Site
  - Bad Berka, Germany, 99438
    - Novartis Investigative Site
  - Bad Oeynhausen, Germany, 32545
    - Novartis Investigative Site
  - Baden-Baden, Germany, 76532
    - Novartis Investigative Site
  - Berlin, Germany, 12203
    - Novartis Investigative Site
  - Berlin, Germany, 12683
    - Novartis Investigative Site
  - Berlin, Germany, 13187
    - Novartis Investigative Site
  - Berlin, Germany, 10405
    - Novartis Investigative Site
  - Berlin, Germany, 12526
    - Novartis Investigative Site
  - Bernburg, Germany, 06406
    - Novartis Investigative Site
  - Bochum, Germany, 44791
    - Novartis Investigative Site
  - Buchholz in der Nordheide, Germany, 21244
    - Novartis Investigative Site
  - Chemnitz, Germany, 09117
    - Novartis Investigative Site
  - Chemnitz, Germany, 09113
    - Novartis Investigative Site
  - Dorsten, Germany, 46282
    - Novartis Investigative Site
  - Dortmund, Germany, 44379
    - Novartis Investigative Site
  - Dortmund, Germany, 44263
    - Novartis Investigative Site
  - Dortmund, Germany, 44309
    - Novartis Investigative Site
  - Dresden, Germany, 01307
    - Novartis Investigative Site
  - Duisburg, Germany, 47137
    - Novartis Investigative Site
  - Duisburg, Germany, 47228
    - Novartis Investigative Site
  - Düssledorf, Germany, 40217
    - Novartis Investigative Site
  - Erfurt, Germany, 99089
    - Novartis Investigative Site
  - Erfurt, Germany, 99097
    - Novartis Investigative Site
  - Erlangen, Germany, 91054
    - Novartis Investigative Site
  - Eschwege, Germany, 37269
    - Novartis Investigative Site
  - Esslingen, Germany, 73730
    - Novartis Investigative Site
  - Frankfurt, Germany, 65929
    - Novartis Investigative Site
  - Frankfurt, Germany, 60316
    - Novartis Investigative Site
  - Friesoythe, Germany, 26169
    - Novartis Investigative Site
  - Gera, Germany, 07548
    - Novartis Investigative Site
  - Gotha, Germany, 99867
    - Novartis Investigative Site
  - Greifswald, Germany, 17475
    - Novartis Investigative Site
  - Guetersloh, Germany, 33332
    - Novartis Investigative Site
  - Hamburg, Germany, 22457
    - Novartis Investigative Site
  - Heidelberg, Germany, 69120
    - Novartis Investigative Site
  - Heidenheim, Germany, 89522
    - Novartis Investigative Site
  - Hennigsdorf, Germany, 16761
    - Novartis Investigative Site
  - Herford, Germany, 32049
    - Novartis Investigative Site
  - Hoyerswerda, Germany, 02977
    - Novartis Investigative Site
  - Kaufbeuren, Germany, 87600
    - Novartis Investigative Site
  - Koblenz, Germany, 56073
    - Novartis Investigative Site
  - Koeln-Nippes, Germany, 50733
    - Novartis Investigative Site
  - Langen, Germany, 63225
    - Novartis Investigative Site
  - Lemgo, Germany, 32657
    - Novartis Investigative Site
  - Leverkusen, Germany, 51379
    - Novartis Investigative Site
  - Lüneburg, Germany, 21339
    - Novartis Investigative Site
  - Mannheim, Germany, 68167
    - Novartis Investigative Site
  - Marburg, Germany, 35039
    - Novartis Investigative Site
  - Marl, Germany, 45768
    - Novartis Investigative Site
  - Memmingen, Germany, 87700
    - Novartis Investigative Site
  - Moenchengladbach, Germany, 41063
    - Novartis Investigative Site
  - Muelheim, Germany, 45468
    - Novartis Investigative Site
  - Muenchen, Germany, 81379
    - Novartis Investigative Site
  - Neumünster, Germany, 24534
    - Novartis Investigative Site
  - Neunkirchen, Germany, 66538
    - Novartis Investigative Site
  - Neuss, Germany, 41464
    - Novartis Investigative Site
  - Neustadt A.d. Aisch, Germany, 91413
    - Novartis Investigative Site
  - Neuwied, Germany, 56564
    - Novartis Investigative Site
  - Nürnberg, Germany, 90419
    - Novartis Investigative Site
  - Ribnitz-Damgarten, Germany, 18311
    - Novartis Investigative Site
  - Rostock, Germany, 18057
    - Novartis Investigative Site
  - Rotenburg, Germany, 27356
    - Novartis Investigative Site
  - Schoenebeck, Germany, 39218
    - Novartis Investigative Site
  - Schwabach, Germany, 91126
    - Novartis Investigative Site
  - Schwalmstadt, Germany, 34613
    - Novartis Investigative Site
  - Singen, Germany, 78224
    - Novartis Investigative Site
  - Soest, Germany, 59494
    - Novartis Investigative Site
  - Sonneberg, Germany, 96515
    - Novartis Investigative Site
  - Speyer, Germany, 67346
    - Novartis Investigative Site
  - Stade, Germany, 21682
    - Novartis Investigative Site
  - Stadtlohn, Germany, 48703
    - Novartis Investigative Site
  - Stuttgart, Germany, 70376
    - Novartis Investigative Site
  - Suhl, Germany, 98527
    - Novartis Investigative Site
  - Torgau, Germany, 04860
    - Novartis Investigative Site
  - Trier, Germany, 54292
    - Novartis Investigative Site
  - Tuebingen, Germany, 72076
    - Novartis Investigative Site
  - Ulm, Germany, 89081
    - Novartis Investigative Site
  - Vechta, Germany, 49377
    - Novartis Investigative Site
  - Wesel, Germany, 46483
    - Novartis Investigative Site
  - Witten, Germany, 58455
    - Novartis Investigative Site
  - Worms, Germany, 67550
    - Novartis Investigative Site
  - Wuerzburg, Germany, 97078
    - Novartis Investigative Site
  - Wuppertal, Germany, 42109
    - Novartis Investigative Site
  - Wurzen, Germany, 04808
    - Novartis Investigative Site
- Schleswig Holstein
  - Flensburg, Schleswig Holstein, Germany, 24939
    - Novartis Investigative Site
Greece
- - Athens, Greece, 115 27
    - Novartis Investigative Site
  - Athens, Greece, 115 28
    - Novartis Investigative Site
  - Athens, Greece, 115 21
    - Novartis Investigative Site
  - Volos, Greece, GR 38222
    - Novartis Investigative Site
- Evros
  - Alexandroupolis, Evros, Greece, 681 00
    - Novartis Investigative Site
- GR
  - Voula, GR, Greece, 166 73
    - Novartis Investigative Site
Hungary
- - Budapest, Hungary, H 1096
    - Novartis Investigative Site
  - Budapest, Hungary, H-1032
    - Novartis Investigative Site
  - Budapest, Hungary, 1096
    - Novartis Investigative Site
  - Budapest, Hungary, H-1115
    - Novartis Investigative Site
  - Debrecen, Hungary, 4032
    - Novartis Investigative Site
  - Eger, Hungary, H-3300
    - Novartis Investigative Site
  - Gyor, Hungary, H-9023
    - Novartis Investigative Site
  - Kalocsa, Hungary, 6300
    - Novartis Investigative Site
  - Kecskemet, Hungary, 6000
    - Novartis Investigative Site
  - Kistarcsa, Hungary, 2143
    - Novartis Investigative Site
  - Mako, Hungary, 6900
    - Novartis Investigative Site
  - Szeged, Hungary, H-6725
    - Novartis Investigative Site
  - Szolnok, Hungary, 5004
    - Novartis Investigative Site
Iceland
- - Reykjavik, Iceland, IS-101
    - Novartis Investigative Site
Italy
- - Pozzuoli, Italy, 80078
    - Novartis Investigative Site
- AP
  - San Benedetto del Tronto, AP, Italy, 63039
    - Novartis Investigative Site
- AR
  - Arezzo, AR, Italy, 52100
    - Novartis Investigative Site
- BA
  - Acquaviva delle Fonti, BA, Italy, 70021
    - Novartis Investigative Site
  - Altamura, BA, Italy, 70022
    - Novartis Investigative Site
  - Cassano delle Murge, BA, Italy, 70020
    - Novartis Investigative Site
- BG
  - Treviglio, BG, Italy, 24047
    - Novartis Investigative Site
- CA
  - Cagliari, CA, Italy, 09134
    - Novartis Investigative Site
- CT
  - Catania, CT, Italy, 95100
    - Novartis Investigative Site
- LO
  - Lodi, LO, Italy, 26900
    - Novartis Investigative Site
- LT
  - Latina, LT, Italy, 04100
    - Novartis Investigative Site
- ME
  - Messina, ME, Italy, 98125
    - Novartis Investigative Site
- MI
  - Cernusco sul Naviglio, MI, Italy, 20063
    - Novartis Investigative Site
  - Legnano, MI, Italy, 20025
    - Novartis Investigative Site
- Mount
  - Matera, Mount, Italy, 75100
    - Novartis Investigative Site
- PC
  - Piacenza, PC, Italy, 29100
    - Novartis Investigative Site
- PN
  - Pordenone, PN, Italy, 33170
    - Novartis Investigative Site
- RE
  - Reggio Emilia, RE, Italy, 42123
    - Novartis Investigative Site
  - Scandiano, RE, Italy, 42019
    - Novartis Investigative Site
- RM
  - Roma, RM, Italy, 00152
    - Novartis Investigative Site
  - Roma, RM, Italy, 00189
    - Novartis Investigative Site
  - Roma, RM, Italy, 00135
    - Novartis Investigative Site
  - Roma, RM, Italy, 00177
    - Novartis Investigative Site
- SI
  - Siena, SI, Italy, 53100
    - Novartis Investigative Site
- SR
  - Siracusa, SR, Italy, 96100
    - Novartis Investigative Site
- SS
  - Sassari, SS, Italy, 07100
    - Novartis Investigative Site
- TO
  - Orbassano, TO, Italy, 10043
    - Novartis Investigative Site
  - Torino, TO, Italy, 10153
    - Novartis Investigative Site
  - Torino, TO, Italy, 10154
    - Novartis Investigative Site
- VA
  - Busto Arsizio, VA, Italy, 21052
    - Novartis Investigative Site
- VE
  - Chioggia, VE, Italy, 30015
    - Novartis Investigative Site
- VI
  - Vicenza, VI, Italy, 36100
    - Novartis Investigative Site
- VR
  - Verona, VR, Italy, 37134
    - Novartis Investigative Site
- VV
  - Vibo Valentia, VV, Italy, 89900
    - Novartis Investigative Site
Latvia
- - Daugavpils, Latvia, LV-5417
    - Novartis Investigative Site
Lithuania
- - Klaipeda, Lithuania, 92288
    - Novartis Investigative Site
  - Vilnius, Lithuania, LT-08661
    - Novartis Investigative Site
- LT
  - Kaunas, LT, Lithuania, LT-45130
    - Novartis Investigative Site
- LTU
  - Kaunas, LTU, Lithuania, LT-50161
    - Novartis Investigative Site
Poland
- - Bilgoraj, Poland, 23-400
    - Novartis Investigative Site
  - Gdansk, Poland, 80 952
    - Novartis Investigative Site
  - Grodzisk Mazowiecki, Poland, 05-825
    - Novartis Investigative Site
  - Kielce, Poland, 25-317
    - Novartis Investigative Site
  - Krakow, Poland, 31 501
    - Novartis Investigative Site
  - Krakow, Poland, 30-901
    - Novartis Investigative Site
  - Lubin, Poland, 59-301
    - Novartis Investigative Site
  - Lublin, Poland, 20-718
    - Novartis Investigative Site
  - Oswiecim, Poland, 32-600
    - Novartis Investigative Site
  - Rzeszow, Poland, 35-241
    - Novartis Investigative Site
  - Tarnobrzeg, Poland, 39-400
    - Novartis Investigative Site
  - Tarnow, Poland, 33-100
    - Novartis Investigative Site
  - Walbrzych, Poland, 58-309
    - Novartis Investigative Site
- POL
  - Krakow, POL, Poland, 31-121
    - Novartis Investigative Site
Portugal
- - Almada, Portugal, 2801 951
    - Novartis Investigative Site
  - Barreiro, Portugal, 2834-003
    - Novartis Investigative Site
  - Braga, Portugal, 4710243
    - Novartis Investigative Site
  - Lisboa, Portugal, 1500 650
    - Novartis Investigative Site
  - Lisboa, Portugal, 1495-005
    - Novartis Investigative Site
  - Matosinhos, Portugal, 4454-509
    - Novartis Investigative Site
  - Setubal, Portugal, 2910-446
    - Novartis Investigative Site
  - Vila Franca de Xira, Portugal, 2600-009
    - Novartis Investigative Site
Romania
- - Bucharest, Romania, 022322
    - Novartis Investigative Site
  - Sibiu, Romania, 550245
    - Novartis Investigative Site
  - Tirgoviste, Romania, 130095
    - Novartis Investigative Site
- District 4
  - Bucuresti, District 4, Romania, 4204179
    - Novartis Investigative Site
- Jud Cluj
  - Bucharest, Jud Cluj, Romania, 010825
    - Novartis Investigative Site
- Jud. Iasi
  - Craiova, Jud. Iasi, Romania, 200642
    - Novartis Investigative Site
Russian Federation
- - Chelyabinsk, Russian Federation, 454092
    - Novartis Investigative Site
  - Chelyabinsk, Russian Federation, 454000
    - Novartis Investigative Site
  - Chita, Russian Federation, 672039
    - Novartis Investigative Site
  - Gatchina, Russian Federation, 188300
    - Novartis Investigative Site
  - Izhevsk, Russian Federation, 426009
    - Novartis Investigative Site
  - Kazan, Russian Federation, 420012
    - Novartis Investigative Site
  - Kazan, Russian Federation, 420103
    - Novartis Investigative Site
  - Kirov, Russian Federation, 610027
    - Novartis Investigative Site
  - Krasnoyarsk, Russian Federation, 660022
    - Novartis Investigative Site
  - Moscow, Russian Federation, 121359
    - Novartis Investigative Site
  - Moscow, Russian Federation, 127473
    - Novartis Investigative Site
  - Moscow, Russian Federation, 117997
    - Novartis Investigative Site
  - Moscow, Russian Federation, 115280
    - Novartis Investigative Site
  - Moscow, Russian Federation, 127994
    - Novartis Investigative Site
  - Novosibirsk, Russian Federation, 630003
    - Novartis Investigative Site
  - Penza, Russian Federation, 440026
    - Novartis Investigative Site
  - Petrozavodsk, Russian Federation, 185031
    - Novartis Investigative Site
  - Rostov-on-Don, Russian Federation, 344068
    - Novartis Investigative Site
  - Ryazan, Russian Federation, 390026
    - Novartis Investigative Site
  - Saint-Petersburg, Russian Federation, 194044
    - Novartis Investigative Site
  - Saratov, Russian Federation, 410028
    - Novartis Investigative Site
  - St.-Petersburg, Russian Federation, 194044
    - Novartis Investigative Site
  - Tyumen, Russian Federation, 625023
    - Novartis Investigative Site
  - Ufa, Russian Federation, 450071
    - Novartis Investigative Site
  - Vladivostok, Russian Federation, 690002
    - Novartis Investigative Site
  - Volgograd, Russian Federation, 400008
    - Novartis Investigative Site
  - Yaroslavl, Russian Federation, 150047
    - Novartis Investigative Site
  - Zelenograd, Moscow Region, Russian Federation, 124489
    - Novartis Investigative Site
Serbia
- - Belgrade, Serbia, 11000
    - Novartis Investigative Site
  - Belgrade, Serbia, 11 000
    - Novartis Investigative Site
  - Belgrade, Serbia, 11080
    - Novartis Investigative Site
  - Kamenica, Serbia, 21204
    - Novartis Investigative Site
  - Nis, Serbia, 18000
    - Novartis Investigative Site
  - Niska Banja, Serbia, 18205
    - Novartis Investigative Site
Slovakia
- - Brezno, Slovakia, 97701
    - Novartis Investigative Site
  - Poprad, Slovakia, 05845
    - Novartis Investigative Site
  - Trencin, Slovakia, 91171
    - Novartis Investigative Site
- Slovak Republic
  - Dunajska Streda, Slovak Republic, Slovakia, 92901
    - Novartis Investigative Site
  - Skalica, Slovak Republic, Slovakia, 909 82
    - Novartis Investigative Site
  - Zvolen, Slovak Republic, Slovakia, 96001
    - Novartis Investigative Site
Slovenia
- - Celje, Slovenia, 3000
    - Novartis Investigative Site
  - Jesenice, Slovenia, 4270
    - Novartis Investigative Site
  - Ljubljana, Slovenia, 1000
    - Novartis Investigative Site
  - Murska Sobota, Slovenia, 9000
    - Novartis Investigative Site
Spain
- - Leon, Spain, 24080
    - Novartis Investigative Site
  - Madrid, Spain, 28006
    - Novartis Investigative Site
  - Madrid, Spain, 28040
    - Novartis Investigative Site
  - Murcia, Spain, 30003
    - Novartis Investigative Site
  - Zaragoza, Spain, 50009
    - Novartis Investigative Site
- Andalucia
  - Granada, Andalucia, Spain, 18014
    - Novartis Investigative Site
  - Granada, Andalucia, Spain, 18012
    - Novartis Investigative Site
  - Malaga, Andalucia, Spain, 29010
    - Novartis Investigative Site
  - Sanlucar de Barrameda, Andalucia, Spain, 11540
    - Novartis Investigative Site
  - Sevilla, Andalucia, Spain, 41013
    - Novartis Investigative Site
  - Sevilla, Andalucia, Spain, 41009
    - Novartis Investigative Site
  - Sevilla, Andalucia, Spain, 41014
    - Novartis Investigative Site
- Asturias
  - Oviedo, Asturias, Spain, 33006
    - Novartis Investigative Site
- Cadiz
  - Villamartin, Cadiz, Spain, 11650
    - Novartis Investigative Site
- Castilla La Mancha
  - Toledo, Castilla La Mancha, Spain, 45071
    - Novartis Investigative Site
- Castilla Y Leon
  - Salamanca, Castilla Y Leon, Spain, 37007
    - Novartis Investigative Site
  - Soria, Castilla Y Leon, Spain, 42005
    - Novartis Investigative Site
- Cataluna
  - Lleida, Cataluna, Spain, 25198
    - Novartis Investigative Site
- Catalunya
  - Barcelona, Catalunya, Spain, 08036
    - Novartis Investigative Site
  - Terrassa, Catalunya, Spain, 08227
    - Novartis Investigative Site
- Comunidad Valenciana
  - Alicante, Comunidad Valenciana, Spain, 03010
    - Novartis Investigative Site
  - Alicante, Comunidad Valenciana, Spain, 03550
    - Novartis Investigative Site
  - Alzira, Comunidad Valenciana, Spain, 46600
    - Novartis Investigative Site
  - Valencia, Comunidad Valenciana, Spain, 46014
    - Novartis Investigative Site
  - Valencia, Comunidad Valenciana, Spain, 46010
    - Novartis Investigative Site
  - Valencia, Comunidad Valenciana, Spain, 46015
    - Novartis Investigative Site
  - Valencia, Comunidad Valenciana, Spain, 46017
    - Novartis Investigative Site
- Extremadura
  - Caceres, Extremadura, Spain, 10003
    - Novartis Investigative Site
- Galicia
  - La Coruna, Galicia, Spain, 15006
    - Novartis Investigative Site
  - Santiago de Compostela, Galicia, Spain, 15706
    - Novartis Investigative Site
- Las Palmas De G.C
  - Las Palmas de Gran Canaria, Las Palmas De G.C, Spain, 35010
    - Novartis Investigative Site
- Madrid
  - Alcorcon, Madrid, Spain, 28922
    - Novartis Investigative Site
  - Fuenlabrada, Madrid, Spain, 28942
    - Novartis Investigative Site
- Murcia
  - Cartagena, Murcia, Spain, 30202
    - Novartis Investigative Site
  - El Palmar, Murcia, Spain, 30120
    - Novartis Investigative Site
- Pais Vasco
  - Bilbao, Pais Vasco, Spain, 48013
    - Novartis Investigative Site
  - Galdakano, Pais Vasco, Spain, 48960
    - Novartis Investigative Site
- Santa Cruz De Tenerife
  - La Laguna, Santa Cruz De Tenerife, Spain, 38320
    - Novartis Investigative Site
- Valencia
  - Manises, Valencia, Spain, 46940
    - Novartis Investigative Site
Switzerland
- - Basel, Switzerland, 4031
    - Novartis Investigative Site
  - Geneve 14, Switzerland, 1211
    - Novartis Investigative Site
  - Liestal, Switzerland, 4410
    - Novartis Investigative Site
  - Lugano, Switzerland, 6903
    - Novartis Investigative Site
United Kingdom
- - Barnet, United Kingdom, EN5 3DJ
    - Novartis Investigative Site
  - Cardiff, United Kingdom, CF14 4XW
    - Novartis Investigative Site
  - Dundee, United Kingdom, DD1 9SY
    - Novartis Investigative Site
  - Liverpool, United Kingdom, L9 7AL
    - Novartis Investigative Site
  - London, United Kingdom, SW17 ORE
    - Novartis Investigative Site
  - Swindon, United Kingdom, SN3 6BB
    - Novartis Investigative Site
- County Durham
  - Durham, County Durham, United Kingdom, DH1 5TW
    - Novartis Investigative Site
- Dorset
  - Dorchester, Dorset, United Kingdom, DT1 2JY
    - Novartis Investigative Site
- GBR
  - Peterborough, GBR, United Kingdom, PE3 6DA
    - Novartis Investigative Site
- Tyne And Wear
  - Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
    - 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Systolic blood pressure ≥ 125 mmHg
Admitted for Acute Heart Failure (AHF)
Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening
eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m^2

Exclusion Criteria:

Dyspnea (non-cardiac causes)
T > 38.5°C
Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.
AHF due to significant arrhythmias
Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).

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: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serelaxin + Standard of Care Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.	Drug: Serelaxin 30 µg/kg/day IV infusion Other Names: RLX030 Drug: Standard of Care This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Other: Standard of Care (SOC) All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.	Drug: Standard of Care This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Participant Group / Arm

Intervention / Treatment

Experimental: Serelaxin + Standard of Care

Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.

Drug: Serelaxin

30 µg/kg/day IV infusion

Other Names:

RLX030

Drug: Standard of Care

This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Other: Standard of Care (SOC)

All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Drug: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 Time Frame: 5 days	In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 Time Frame: 14 days	WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.	14 days
Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 Time Frame: 5 days	Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.	5 days
Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 Time Frame: 14 days	Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine.	14 days
Length of Index Hospital Stay Time Frame: 30 Days	Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.	30 Days
Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients Time Frame: Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days		Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire. Time Frame: Baseline, Day 5, Day 14	EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).	Baseline, Day 5, Day 14

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

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)

January 31, 2014

Primary Completion (Actual)

March 26, 2017

Study Completion (Actual)

April 25, 2017

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CRLX030A3301
2013-002513-35 (EudraCT Number)

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

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 (Estimate)

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

Clinical Trials on Acute Heart Failure (AHF)

Clinical Trials on Serelaxin

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