Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

February 10, 2021 updated by: Novartis Pharmaceuticals

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

Study Overview

Status

No longer available

Conditions

Heart Failure With Reduced Ejection Fraction (HF-rEF)

Intervention / Treatment

Drug: LCZ696

Study Type

Expanded Access

Expanded Access Type

Intermediate-size Population

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

Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Novartis Investigative Site
  - North Ryde, New South Wales, Australia, 2109
    - Novartis Investigative Site
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Novartis Investigative Site
Austria
- - Krems, Austria, A-3500
    - Novartis Investigative Site
  - Salzburg, Austria
    - Novartis Investigative Site
  - St. Poelten, Austria, 3100
    - Novartis Investigative Site
  - Vienna, Austria, 1130
    - Novartis Investigative Site
  - Wien, Austria, A-1090
    - Novartis Investigative Site
Brazil
- BA
  - Salvador, BA, Brazil, 41180-780
    - Novartis Investigative Site
- CE
  - Fortaleza, CE, Brazil, 60864-190
    - Novartis Investigative Site
- MG
  - Belo Horizonte, MG, Brazil, 30170-040
    - Novartis Investigative Site
- RS
  - Porto Alegre, RS, Brazil, 90620 001
    - Novartis Investigative Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Novartis Investigative Site
Croatia
- HRV
  - Varazdin, HRV, Croatia, 42000
    - Novartis Investigative Site
Cyprus
- - Limassol, Cyprus, 3021
    - Novartis Investigative Site
  - Nicosia, Cyprus, 1086
    - Novartis Investigative Site
  - Nicosia, Cyprus, 2024
    - Novartis Investigative Site
  - Nicosia, Cyprus, 2029
    - Novartis Investigative Site
  - Nicosia, Cyprus, 2042
    - Novartis Investigative Site
  - Nicosia, Cyprus, 2047
    - Novartis Investigative Site
France
- - Amiens cedex 1, France, 80054
    - Novartis Investigative Site
  - Amilly, France, 45200
    - Novartis Investigative Site
  - Angers Cedex 9, France, 49933
    - Novartis Investigative Site
  - Antibes, France, 06600
    - Novartis Investigative Site
  - Aressy, France, 64320
    - Novartis Investigative Site
  - Avignon, France, 84000
    - Novartis Investigative Site
  - Avignon Cedex 2, France, 84082
    - Novartis Investigative Site
  - Bayeux, France, 14401
    - Novartis Investigative Site
  - Beziers Cedex, France, 34525
    - Novartis Investigative Site
  - Bobigny, France, 93009
    - Novartis Investigative Site
  - Brest, France, 29609
    - Novartis Investigative Site
  - Brest Armees, France, 29240
    - Novartis Investigative Site
  - Bron, France, 69677
    - Novartis Investigative Site
  - Bron Cedex, France, 69677
    - Novartis Investigative Site
  - Caen, France, 14000
    - Novartis Investigative Site
  - Caen Cedex, France, 14033
    - Novartis Investigative Site
  - Cambrai Cedex, France, 59507
    - Novartis Investigative Site
  - Cannes Cedex, France, 06414
    - Novartis Investigative Site
  - Chambéry cedex, France, 73011
    - Novartis Investigative Site
  - Chaumont Cedex, France, 52014
    - Novartis Investigative Site
  - Cherbourg Octeville, France, 50102
    - Novartis Investigative Site
  - Clamart, France, 92140
    - Novartis Investigative Site
  - Clermont-Ferrand cedex 1, France, 63003
    - Novartis Investigative Site
  - Compiègne cedex, France, 60321
    - Novartis Investigative Site
  - Contamine Sur Arve, France, 74130
    - Novartis Investigative Site
  - Corbeil Essonnes, France, 91100
    - Novartis Investigative Site
  - Cornebarrieu, France, 31700
    - Novartis Investigative Site
  - Dijon, France, 21000
    - Novartis Investigative Site
  - Eaubonne, France, 95600
    - Novartis Investigative Site
  - Honfleur Cedex, France, 14601
    - Novartis Investigative Site
  - Hyeres, France, 83418
    - Novartis Investigative Site
  - La Roche sur Yon Cedex, France, 85295
    - Novartis Investigative Site
  - La Seyne sur mer, France, 83500
    - Novartis Investigative Site
  - La Tronche, France, 38700
    - Novartis Investigative Site
  - Lille Cedex, France, 59037
    - Novartis Investigative Site
  - Lille Cedex, France, 59003
    - Novartis Investigative Site
  - Limoges, France
    - Novartis Investigative Site
  - Lyon, France, F-69001
    - Novartis Investigative Site
  - Lyon, France, 69394
    - Novartis Investigative Site
  - Lyon CEDEX 04, France, 69317
    - Novartis Investigative Site
  - Marseille, France, 13008
    - Novartis Investigative Site
  - Marseille, France, 13385
    - Novartis Investigative Site
  - Marseille Cedex 05, France, 13385
    - Novartis Investigative Site
  - Marseille Cedex 20, France, 13915
    - Novartis Investigative Site
  - Metz Cedex, France, F-57038
    - Novartis Investigative Site
  - Metz-Tessy, France, 74370
    - Novartis Investigative Site
  - Monaco, France, 98000
    - Novartis Investigative Site
  - Montbeliard Cedex, France, 25209
    - Novartis Investigative Site
  - Montpellier, France, 34295
    - Novartis Investigative Site
  - Montpellier Cedex, France, 34960
    - Novartis Investigative Site
  - Morlaix Cedex, France, 29672
    - Novartis Investigative Site
  - Moulins Cedex, France, 03006
    - Novartis Investigative Site
  - Mulhouse Cedex, France, 68051
    - Novartis Investigative Site
  - Mâcon Cedex, France, 71018
    - Novartis Investigative Site
  - Nantes Cedex 1, France, 44093
    - Novartis Investigative Site
  - Neuilly-sur-seine, France, 92200
    - Novartis Investigative Site
  - Nice Cedex 1, France, 06003
    - Novartis Investigative Site
  - Nice Cedex 2, France, 06105
    - Novartis Investigative Site
  - Nimes, France, 30029
    - Novartis Investigative Site
  - Paris Cedex 10, France, 75475
    - Novartis Investigative Site
  - Paris Cedex 13, France, 75651
    - Novartis Investigative Site
  - Paris Cedex 14, France, 75679
    - Novartis Investigative Site
  - Pau Cedex, France, 64046
    - Novartis Investigative Site
  - Perpignan, France, 66000
    - Novartis Investigative Site
  - Pessac Cedex, France, 33604
    - Novartis Investigative Site
  - Poitiers, France, 86021
    - Novartis Investigative Site
  - Pont L'Abbe, France, 29123
    - Novartis Investigative Site
  - Pontarlier Cedex, France, 25304
    - Novartis Investigative Site
  - Pontoise, France, F-95300
    - Novartis Investigative Site
  - Rennes Cedex 9, France, 35033
    - Novartis Investigative Site
  - Rouen Cedex, France, 76031
    - Novartis Investigative Site
  - Rumilly, France, 74150
    - Novartis Investigative Site
  - Saint Denis, France, 97400
    - Novartis Investigative Site
  - Saint Denis, France, 97490
    - Novartis Investigative Site
  - Saint Etienne Cedex 2, France, 42055
    - Novartis Investigative Site
  - Saint Palais, France, 64120
    - Novartis Investigative Site
  - Saint-Germain-en-Laye, France, 78105
    - Novartis Investigative Site
  - St Jean, France, 31240
    - Novartis Investigative Site
  - St. Etienne, France, 42100
    - Novartis Investigative Site
  - Strasbourg, France, 67091
    - Novartis Investigative Site
  - Thonon Les Bains Cedex, France, 74203
    - Novartis Investigative Site
  - Toulouse, France, 31054
    - Novartis Investigative Site
  - Toulouse Cedex, France, 31059
    - Novartis Investigative Site
  - Tours, France, 37044
    - Novartis Investigative Site
  - Valence Cedex 9, France, 26953
    - Novartis Investigative Site
  - Valenciennes Cedex, France, 59322
    - Novartis Investigative Site
  - Vandoeuvre Les Nancy, France, 54511
    - Novartis Investigative Site
  - Vichy, France, 03201
    - Novartis Investigative Site
  - Villefranche sur Saone, France, 69655
    - Novartis Investigative Site
  - Wattrelos, France, 59393
    - Novartis Investigative Site
- Bouches Du Rhone
  - Marseille cedex 20, Bouches Du Rhone, France, 13915
    - Novartis Investigative Site
- Cedex
  - Bron, Cedex, France, 69677
    - Novartis Investigative Site
  - Caen, Cedex, France, 14033
    - Novartis Investigative Site
- France / La Reunion
  - Saint Denis, France / La Reunion, France, 97405
    - Novartis Investigative Site
Germany
- - Ahlen, Germany, 59227
    - Novartis Investigative Site
  - Augsburg, Germany, 86199
    - Novartis Investigative Site
  - Bad Endbach, Germany, 35080
    - Novartis Investigative Site
  - Bad Homburg, Germany, 61348
    - Novartis Investigative Site
  - Bad Kreuznach, Germany, 55543
    - Novartis Investigative Site
  - Bad Krozingen, Germany, 79189
    - Novartis Investigative Site
  - Bad Oeynhausen, Germany, 32545
    - Novartis Investigative Site
  - Berlin, Germany, 13353
    - Novartis Investigative Site
  - Berlin, Germany, 10789
    - Novartis Investigative Site
  - Bielefeld, Germany, 33604
    - Novartis Investigative Site
  - Bielefeld, Germany, 33602
    - Novartis Investigative Site
  - Bonn, Germany, 53115
    - Novartis Investigative Site
  - Chemnitz, Germany, 09117
    - Novartis Investigative Site
  - Chemnitz, Germany, 09130
    - Novartis Investigative Site
  - Chemnitz, Germany, 09126
    - Novartis Investigative Site
  - Cologne, Germany, 51105
    - Novartis Investigative Site
  - Dessau-Rosslau, Germany, 06847
    - Novartis Investigative Site
  - Diepholz, Germany, 49356
    - Novartis Investigative Site
  - Dinslaken, Germany, 46535
    - Novartis Investigative Site
  - Dortmund, Germany, 44309
    - Novartis Investigative Site
  - Dresden, Germany, 01307
    - Novartis Investigative Site
  - Dresden, Germany, 01277
    - Novartis Investigative Site
  - Dresden, Germany, 01067
    - Novartis Investigative Site
  - Dusseldorf, Germany, 40477
    - Novartis Investigative Site
  - Eilenburg, Germany, D 04838
    - Novartis Investigative Site
  - Eschwege, Germany, 37269
    - Novartis Investigative Site
  - Essen, Germany, 45355
    - Novartis Investigative Site
  - Frankfurt, Germany, 60590
    - Novartis Investigative Site
  - Frankfurt, Germany, 60431
    - Novartis Investigative Site
  - Frankfurt, Germany, 60322
    - Novartis Investigative Site
  - Frankfurt, Germany, 60439
    - Novartis Investigative Site
  - Friedrichroda, Germany, 99894
    - Novartis Investigative Site
  - Goettingen, Germany, 37075
    - Novartis Investigative Site
  - Gronau, Germany, 31028
    - Novartis Investigative Site
  - Guenzburg, Germany, 89312
    - Novartis Investigative Site
  - Hamburg, Germany, 22457
    - Novartis Investigative Site
  - Hannover, Germany, 30559
    - Novartis Investigative Site
  - Hannover, Germany, 30159
    - Novartis Investigative Site
  - Hassfurt, Germany, 97437
    - Novartis Investigative Site
  - Hassloch, Germany, 67454
    - Novartis Investigative Site
  - Hohenstein-Ernstthal, Germany, 09337
    - Novartis Investigative Site
  - Jena, Germany, 07740
    - Novartis Investigative Site
  - Karlsruhe, Germany, 76135
    - Novartis Investigative Site
  - Kassel, Germany, 34121
    - Novartis Investigative Site
  - Koeln, Germany, 50937
    - Novartis Investigative Site
  - Koeln, Germany, 51605
    - Novartis Investigative Site
  - Köthen, Germany, 06366
    - Novartis Investigative Site
  - Lauchringen, Germany, 79787
    - Novartis Investigative Site
  - Leipzig, Germany, 04103
    - Novartis Investigative Site
  - Ludwigshafen, Germany, 67063
    - Novartis Investigative Site
  - Magdeburg, Germany, 39120
    - Novartis Investigative Site
  - Magdeburg, Germany, 39114
    - Novartis Investigative Site
  - Mainz, Germany, 55131
    - Novartis Investigative Site
  - Mannheim, Germany, 68167
    - Novartis Investigative Site
  - Marl, Germany, 45768
    - Novartis Investigative Site
  - Muenchen, Germany, 80636
    - Novartis Investigative Site
  - Munchen, Germany, 80336
    - Novartis Investigative Site
  - Munster, Germany, 48153
    - Novartis Investigative Site
  - Oldenburg, Germany, 26133
    - Novartis Investigative Site
  - Pressath, Germany, 92690
    - Novartis Investigative Site
  - Rostock, Germany, 18107
    - Novartis Investigative Site
  - Ulm, Germany, 89081
    - Novartis Investigative Site
  - Weinheim, Germany, 69469
    - Novartis Investigative Site
  - Wildeshausen, Germany, 27793
    - Novartis Investigative Site
  - Wolfratshausen, Germany, 82515
    - Novartis Investigative Site
  - Wuerzburg, Germany, 97080
    - Novartis Investigative Site
- OT Bartmannshagen
  - Suderholz, OT Bartmannshagen, Germany, 18516
    - Novartis Investigative Site
Greece
- - Athens, Greece, 11527
    - Novartis Investigative Site
  - Athens, Greece, 115 27
    - Novartis Investigative Site
  - Athens, Greece, 115 28
    - Novartis Investigative Site
  - Athens, Greece, 115 21
    - Novartis Investigative Site
  - Athens, Greece, 11526
    - Novartis Investigative Site
  - Athens, Greece, GR14564
    - Novartis Investigative Site
  - Athens, Greece, 106 76
    - Novartis Investigative Site
  - Athens, Greece, 145 61
    - Novartis Investigative Site
  - Athens, Greece, 115 26
    - Novartis Investigative Site
  - Athens, Greece, 11521
    - Novartis Investigative Site
  - Athens, Greece, 15127
    - Novartis Investigative Site
  - Athens, Greece, 15562
    - Novartis Investigative Site
  - Athens, Greece, 176 74
    - Novartis Investigative Site
  - Chaidari, Greece, 12461
    - Novartis Investigative Site
  - Chios, Greece, 821 00
    - Novartis Investigative Site
  - Edessa, Greece, 58200
    - Novartis Investigative Site
  - Elefsina, Greece, 19600
    - Novartis Investigative Site
  - Glyfada, Greece, 16675
    - Novartis Investigative Site
  - Heraklion, Greece, 714 09
    - Novartis Investigative Site
  - Heraklion - Crete, Greece, 711 10
    - Novartis Investigative Site
  - Ioannina, Greece, 45001
    - Novartis Investigative Site
  - Kalamata, Greece, 241 00
    - Novartis Investigative Site
  - Karditsa, Greece, 43100
    - Novartis Investigative Site
  - Katerini, Greece, 601 00
    - Novartis Investigative Site
  - Kavala, Greece, 65 500
    - Novartis Investigative Site
  - Kerkyra, Greece, 49100
    - Novartis Investigative Site
  - Kilkis, Greece, 611 00
    - Novartis Investigative Site
  - Kozani, Greece, 50100
    - Novartis Investigative Site
  - Maroussi, Greece, 15125
    - Novartis Investigative Site
  - Piraeus, Greece, 18454
    - Novartis Investigative Site
  - Piraeus, Greece, 185 36
    - Novartis Investigative Site
  - Rio Patra, Greece, 26504
    - Novartis Investigative Site
  - Thesaloniki, Greece, 55134
    - Novartis Investigative Site
  - Thessaloniki, Greece, 54642
    - Novartis Investigative Site
  - Thessaloniki, Greece, 54636
    - Novartis Investigative Site
  - Thessaloniki, Greece, 552 36
    - Novartis Investigative Site
  - Volos, Greece, GR 38222
    - Novartis Investigative Site
- Evros
  - Alexandroupolis, Evros, Greece, 681 00
    - Novartis Investigative Site
- GR
  - Athens, GR, Greece, 115 27
    - Novartis Investigative Site
  - Athens, GR, Greece, 115 21
    - Novartis Investigative Site
  - Athens, GR, Greece, 14233
    - Novartis Investigative Site
  - Athens, GR, Greece, 115 25
    - Novartis Investigative Site
  - Ioannina, GR, Greece, 451 10
    - Novartis Investigative Site
  - Larissa, GR, Greece, 411 10
    - Novartis Investigative Site
  - Thessaloniki, GR, Greece, 570 10
    - Novartis Investigative Site
  - Thessaloniki, GR, Greece, 546 36
    - Novartis Investigative Site
  - Thessaloniki, GR, Greece, 56429
    - Novartis Investigative Site
  - Tripoli, GR, Greece, 221 00
    - Novartis Investigative Site
  - Voula, GR, Greece, 166 73
    - Novartis Investigative Site
Ireland
- - Co Dublin, Ireland
    - Novartis Investigative Site
  - Dublin, Ireland, 9
    - Novartis Investigative Site
Lebanon
- - Ashrafieh, Lebanon, 166830
    - Novartis Investigative Site
  - Beirut, Lebanon, 1107 2020
    - Novartis Investigative Site
  - Beirut, Lebanon, 6301
    - Novartis Investigative Site
  - Beirut, Lebanon, 166378
    - Novartis Investigative Site
  - Beirut, Lebanon
    - Novartis Investigative Site
  - Beirut, Lebanon, 11-2555
    - Novartis Investigative Site
  - Beirut, Lebanon, 5544
    - Novartis Investigative Site
  - Saida, Lebanon, 652
    - Novartis Investigative Site
  - Tripoli, Lebanon
    - Novartis Investigative Site
Malta
- - Msida, Malta, MSD 2090
    - Novartis Investigative Site
Panama
- - Panama, Panama
    - Novartis Investigative Site
  - Panama City, Panama
    - Novartis Investigative Site
Philippines
- - Makati City, Philippines, 1229
    - Novartis Investigative Site
  - Manila, Philippines, 1000
    - Novartis Investigative Site
- Metro Manila
  - Manila, Metro Manila, Philippines, 1000
    - Novartis Investigative Site
Slovenia
- - Ljubljana, Slovenia, 1000
    - Novartis Investigative Site
Spain
- - Badalona, Spain, 08911
    - Novartis Investigative Site
  - Baleares, Spain, 7014
    - Novartis Investigative Site
  - El Palmar (Murcia), Spain, 30120
    - Novartis Investigative Site
  - Las Palmas de Gran Canaria, Spain, 35010
    - Novartis Investigative Site
  - Las Palmas de Gran Canaria, Spain, 35016
    - Novartis Investigative Site
  - Madrid, Spain, 28046
    - Novartis Investigative Site
  - Madrid, Spain, 28040
    - Novartis Investigative Site
  - Madrid, Spain, 28031
    - Novartis Investigative Site
  - Madrid, Spain, 28023
    - Novartis Investigative Site
  - Salamanca, Spain, 37007
    - Novartis Investigative Site
  - Sevilla, Spain, 41009
    - Novartis Investigative Site
  - Sevilla, Spain, 41010
    - Novartis Investigative Site
  - Zaragoza, Spain, 50009
    - Novartis Investigative Site
  - Zaragoza, Spain, 50015
    - Novartis Investigative Site
- Andalucia
  - Cordoba, Andalucia, Spain, 14004
    - Novartis Investigative Site
  - Garanada, Andalucia, Spain, 18004
    - Novartis Investigative Site
  - Jerez de la Frontera, Andalucia, Spain, 11407
    - Novartis Investigative Site
  - Sevilla, Andalucia, Spain, 41014
    - Novartis Investigative Site
  - Utrera, Andalucia, Spain, 41710
    - Novartis Investigative Site
- Barcelona
  - Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Novartis Investigative Site
- Cadiz
  - Villamartin, Cadiz, Spain, 11650
    - Novartis Investigative Site
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Novartis Investigative Site
  - Torrelavega, Cantabria, Spain, 39300
    - Novartis Investigative Site
- Cataluna
  - Lleida, Cataluna, Spain, 25198
    - Novartis Investigative Site
- Catalunya
  - Barcelona, Catalunya, Spain, 08035
    - Novartis Investigative Site
- Cataluña
  - Salt, Cataluña, Spain, 17190
    - Novartis Investigative Site
- Extremadura
  - Badajoz, Extremadura, Spain, 6011
    - Novartis Investigative Site
- Galicia
  - Pontevedra, Galicia, Spain, 36001
    - Novartis Investigative Site
- La Rioja
  - Logrono, La Rioja, Spain, 26006
    - Novartis Investigative Site
- Las Palmas De G.C
  - Las Palmas de Gran Canaria, Las Palmas De G.C, Spain, 35010
    - Novartis Investigative Site
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Novartis Investigative Site
  - San Sebastian de los Reyes, Madrid, Spain, 28702
    - Novartis Investigative Site
  - San Sebastian de los Reyes, Madrid, Spain, 28703
    - Novartis Investigative Site
- Malaga
  - Marbella, Malaga, Spain, 29603
    - Novartis Investigative Site
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Novartis Investigative Site
- Pais Vasco
  - Bilbao, Pais Vasco, Spain, 48013
    - Novartis Investigative Site
  - Galdakano, Pais Vasco, Spain, 48960
    - Novartis Investigative Site
Switzerland
- LU
  - Luzern, LU, Switzerland, 6004
    - Novartis Investigative Site
United Arab Emirates
- - Abu Dhabi, United Arab Emirates, 51900
    - Novartis Investigative Site
  - Ras Al Khaimah, United Arab Emirates, 4727
    - Novartis Investigative Site
United States
- Florida
  - Vero Beach, Florida, United States, 32960
    - 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

The patient(s) for whom the MPP is sought meets all of the following:

Is suffering from a serious or life-threatening disease or condition
Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)
Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA;
Intolerance to evidence-based target doses should be documented by the treating physician
Meets any other relevant medical criteria for compassionate use of the investigational product

Patients eligible for inclusion in this program have to fulfill all of the following criteria:

Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed.
Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:
• LVEF ≤ 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%)
Patient had a hospitalization for HF within the last 12 months
Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696
Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication).
An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696

Exclusion criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this program:

The patient is eligible for participation in any of the IMP's ongoing clinical trials
The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment.
The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation
History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
Previous history of intolerance to recommended target doses of ARBs
Known history of angioedema
Requirement of concomitant treatment with both ACEIs and ARBs
Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696
Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula
Presence of bilateral renal artery stenosis
Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696
Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696
Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696
Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device.
Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded.
Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD
History of severe pulmonary disease
Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696
Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696
Symptomatic bradycardia or second or third degree heart block without a pacemaker
Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation
Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following:
- History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696.
- Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696
- Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
- Active treatment with cholestyramine or colestipol resins
Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method
- Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent.
- Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Presence of any other disease with a life expectancy of < 3 years
Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.

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?

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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 Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Multiple Patient Program, LCZ696, heart failure, heart failure with reduced ejection fraction, HF-rEF

Additional Relevant MeSH Terms

Other Study ID Numbers

CLCZ696B2318M

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.

Clinical Trials on Heart Failure With Reduced Ejection Fraction (HF-rEF)

Novartis Pharmaceuticals

Completed

Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction (PARALLEL-HF)

Heart Failure With Reduced Ejection Fraction (HF-rEF)

Japan
Novartis Pharmaceuticals

Completed

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)

Heart Failure With Reduced Ejection Fraction (HFrEF) | or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Netherlands, United States
University of Siena
European Association of Cardiovascular Imaging

Active, not recruiting

Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE) (FUTURE-HIT)

Heart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction

Spain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
University Hospital, Akershus
Novartis

Active, not recruiting

Heart Failure in Norway: Clinical Characteristics, Mortality and Health Care Resource Use

Heart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction

Norway
Milton S. Hershey Medical Center

Withdrawn

Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure

Heart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction

United States
Board of Trustees of Illinois State University
University of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaborators

Recruiting

Consistently Assess Signs and Symptom of Heart Failure (CLASS-HF)

Heart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction

United States
Medical University of South Carolina

Completed

LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF)

Heart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction

United States
Milton S. Hershey Medical Center

Completed

Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation

Heart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction

United States
Massachusetts General Hospital
Roche Diagnostics

Recruiting

Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure (PREFER-HF)

Cardiovascular Risk Factor | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction | Heart Failure, Right Sided | Heart Failure With Mid Range Ejection Fraction

United States
Occlutech International AB

Active, not recruiting

Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study (FROST-HF)

Heart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)

United States

Clinical Trials on LCZ696

Novartis Pharmaceuticals

Completed

Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode. (PIONEER-HF)

Acute Heart Failure

United States
Novartis Pharmaceuticals

Completed

Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction (EVALUATE-HF)

Heart Failure and Reduced Ejection Fraction

United States
Novartis Pharmaceuticals

Completed

Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

Hypertension

United States, Spain, Philippines, Guatemala, Russian Federation, Argentina, Puerto Rico
Novartis Pharmaceuticals

Completed

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure (OUTSTEP-HF)

Chronic Heart Failure With Reduced Ejection Fraction

Belgium, Estonia, Denmark, Greece, United Kingdom, Germany, Latvia, Lithuania, Spain, Netherlands, Bulgaria, Finland, Poland, Czechia, Iceland, Sweden, France, Ireland, Norway
Novartis Pharmaceuticals

Completed

Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction (PERSPECTIVE)

Chronic Heart Failure (CHF)

Spain, Croatia, Taiwan, Germany, Italy, United States, Australia, Netherlands, Switzerland, Belgium, United Kingdom, Bulgaria, Lithuania, Russian Federation, France, Argentina, Korea, Republic of, Poland, Canada, Turkey
University Hospital, Montpellier

Completed

Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study (ENTRESTO696)

Chronic Heart Failure | Sleep Apnea Syndrome

France
Novartis Pharmaceuticals

Completed

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension

Essential Hypertension

China, Korea, Republic of, Taiwan, Hong Kong, Thailand, Philippines, Singapore
Novartis Pharmaceuticals

Completed

Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.

Chronic Heart Failure With Reduced Ejection Fraction

Germany
Novartis Pharmaceuticals

Completed

COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure (CONFIDENCE-HF)

Heart Failure | Erectile Dysfunction | Heart Failure, Systolic

Germany
Duke University
National Heart, Lung, and Blood Institute (NHLBI)

Completed

EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

Heart Failure

United States

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Expanded Access Type

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?

Collaborators and Investigators

Sponsor

Study record dates

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 Heart Failure With Reduced Ejection Fraction (HF-rEF)

Clinical Trials on LCZ696

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

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Conditions

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Locations