Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)
1 other identifier
expanded_access
N/A
17 countries
283
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
283 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedFebruary 15, 2021
February 1, 2021
March 10, 2015
February 10, 2021
Conditions
Keywords
Interventions
immediate release film coated tablet in 50 mg, 100 mg, 200 mg, and 400 mg strengths for oral administration.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (286)
Novartis Investigative Site
Vero Beach, Florida, 32960, United States
Novartis Investigative Site
Darlinghurst, New South Wales, 2010, Australia
Novartis Investigative Site
North Ryde, New South Wales, 2109, Australia
Novartis Investigative Site
Perth, Western Australia, 6000, Australia
Novartis Investigative Site
Krems, A-3500, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Sankt Pölten, 3100, Austria
Novartis Investigative Site
Vienna, 1130, Austria
Novartis Investigative Site
Vienna, A-1090, Austria
Novartis Investigative Site
Fortaleza, Ceará, 60864-190, Brazil
Novartis Investigative Site
Salvador, Estado de Bahia, 41180-780, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30170-040, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90620 001, Brazil
Novartis Investigative Site
Varaždin, HRV, 42000, Croatia
Novartis Investigative Site
Limassol, 3021, Cyprus
Novartis Investigative Site
Nicosia, 1086, Cyprus
Novartis Investigative Site
Nicosia, 2024, Cyprus
Novartis Investigative Site
Nicosia, 2029, Cyprus
Novartis Investigative Site
Nicosia, 2042, Cyprus
Novartis Investigative Site
Nicosia, 2047, Cyprus
Novartis Investigative Site
Marseille, Bouches Du Rhone, 13915, France
Novartis Investigative Site
Bron, Cedex, 69677, France
Novartis Investigative Site
Caen, Cedex, 14033, France
Novartis Investigative Site
Saint-Denis, France / La Reunion, 97405, France
Novartis Investigative Site
Brest Armees, France, 29240, France
Novartis Investigative Site
Amiens, 80054, France
Novartis Investigative Site
Amilly, 45200, France
Novartis Investigative Site
Angers, 49933, France
Novartis Investigative Site
Antibes, 06600, France
Novartis Investigative Site
Aressy, 64320, France
Novartis Investigative Site
Avignon, 84000, France
Novartis Investigative Site
Avignon, 84082, France
Novartis Investigative Site
Bayeux, 14401, France
Novartis Investigative Site
Béziers, 34525, France
Novartis Investigative Site
Bobigny, 93009, France
Novartis Investigative Site
Brest, 29609, France
Novartis Investigative Site
Bron, 69677, France
Novartis Investigative Site
Caen, 14000, France
Novartis Investigative Site
Caen, 14033, France
Novartis Investigative Site
Cambrai, 59507, France
Novartis Investigative Site
Cannes, 06414, France
Novartis Investigative Site
Chambéry, 73011, France
Novartis Investigative Site
Chaumont, 52014, France
Novartis Investigative Site
Cherbourg Octeville, 50102, France
Novartis Investigative Site
Clamart, 92140, France
Novartis Investigative Site
Clermont-Ferrand, 63003, France
Novartis Investigative Site
Compiègne, 60321, France
Novartis Investigative Site
Contamine-sur-Arve, 74130, France
Novartis Investigative Site
Corbeil-Essonnes, 91100, France
Novartis Investigative Site
Cornebarrieu, 31700, France
Novartis Investigative Site
Dijon, 21000, France
Novartis Investigative Site
Eaubonne, 95600, France
Novartis Investigative Site
Honfleur, 14601, France
Novartis Investigative Site
Hyères, 83418, France
Novartis Investigative Site
La Roche-sur-Yon, 85295, France
Novartis Investigative Site
La Seyne-sur-Mer, 83500, France
Novartis Investigative Site
La Tronche, 38700, France
Novartis Investigative Site
Lille, 59003, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Limoges, France
Novartis Investigative Site
Lyon, 69317, France
Novartis Investigative Site
Lyon, 69394, France
Novartis Investigative Site
Lyon, F-69001, France
Novartis Investigative Site
Marseille, 13008, France
Novartis Investigative Site
Marseille, 13385, France
Novartis Investigative Site
Marseille, 13915, France
Novartis Investigative Site
Mâcon, 71018, France
Novartis Investigative Site
Metz, F-57038, France
Novartis Investigative Site
Metz-Tessy, 74370, France
Novartis Investigative Site
Monaco, 98000, France
Novartis Investigative Site
Montbéliard, 25209, France
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Montpellier, 34295, France
Novartis Investigative Site
Montpellier, 34960, France
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Morlaix, 29672, France
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Moulins, 03006, France
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Mulhouse, 68051, France
Novartis Investigative Site
Nantes, 44093, France
Novartis Investigative Site
Neuilly-sur-Seine, 92200, France
Novartis Investigative Site
Nice, 06003, France
Novartis Investigative Site
Nice, 06105, France
Novartis Investigative Site
Nîmes, 30029, France
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Paris, 75651, France
Novartis Investigative Site
Paris, 75679, France
Novartis Investigative Site
Pau, 64046, France
Novartis Investigative Site
Perpignan, 66000, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Pont-l'Abbé, 29123, France
Novartis Investigative Site
Pontarlier, 25304, France
Novartis Investigative Site
Pontoise, F-95300, France
Novartis Investigative Site
Rennes, 35033, France
Novartis Investigative Site
Rouen, 76031, France
Novartis Investigative Site
Rumilly, 74150, France
Novartis Investigative Site
Saint-Denis, 97400, France
Novartis Investigative Site
Saint-Denis, 97490, France
Novartis Investigative Site
Saint-Etienne, 42055, France
Novartis Investigative Site
Saint-Etienne, 42100, France
Novartis Investigative Site
Saint-Germain-en-Laye, 78105, France
Novartis Investigative Site
Saint-Palais, 64120, France
Novartis Investigative Site
St.-Jean, 31240, France
Novartis Investigative Site
Strasbourg, 67091, France
Novartis Investigative Site
Thonon-les-Bains, 74203, France
Novartis Investigative Site
Toulouse, 31054, France
Novartis Investigative Site
Toulouse, 31059, France
Novartis Investigative Site
Tours, 37044, France
Novartis Investigative Site
Valence, 26953, France
Novartis Investigative Site
Valenciennes, 59322, France
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511, France
Novartis Investigative Site
Vichy, 03201, France
Novartis Investigative Site
Villefranche-sur-Saône, 69655, France
Novartis Investigative Site
Wattrelos, 59393, France
Novartis Investigative Site
Süderholz, OT Bartmannshagen, 18516, Germany
Novartis Investigative Site
Ahlen, 59227, Germany
Novartis Investigative Site
Augsburg, 86199, Germany
Novartis Investigative Site
Bad Endbach, 35080, Germany
Novartis Investigative Site
Bad Homburg, 61348, Germany
Novartis Investigative Site
Bad Kreuznach, 55543, Germany
Novartis Investigative Site
Bad Krozingen, 79189, Germany
Novartis Investigative Site
Bad Oeynhausen, 32545, Germany
Novartis Investigative Site
Berlin, 10789, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Bielefeld, 33602, Germany
Novartis Investigative Site
Bielefeld, 33604, Germany
Novartis Investigative Site
Bonn, 53115, Germany
Novartis Investigative Site
Chemnitz, 09117, Germany
Novartis Investigative Site
Chemnitz, 09126, Germany
Novartis Investigative Site
Chemnitz, 09130, Germany
Novartis Investigative Site
Cologne, 50937, Germany
Novartis Investigative Site
Cologne, 51105, Germany
Novartis Investigative Site
Cologne, 51605, Germany
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Dessau, 06847, Germany
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Diepholz, 49356, Germany
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Dinslaken, 46535, Germany
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Dortmund, 44309, Germany
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Dresden, 01067, Germany
Novartis Investigative Site
Dresden, 01277, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Düsseldorf, 40477, Germany
Novartis Investigative Site
Eilenburg, D 04838, Germany
Novartis Investigative Site
Eschwege, 37269, Germany
Novartis Investigative Site
Essen, 45355, Germany
Novartis Investigative Site
Frankfurt, 60322, Germany
Novartis Investigative Site
Frankfurt, 60431, Germany
Novartis Investigative Site
Frankfurt, 60439, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
Friedrichroda, 99894, Germany
Novartis Investigative Site
Göttingen, 37075, Germany
Novartis Investigative Site
Gronau, 31028, Germany
Novartis Investigative Site
Günzburg, 89312, Germany
Novartis Investigative Site
Hamburg, 22457, Germany
Novartis Investigative Site
Hanover, 30159, Germany
Novartis Investigative Site
Hanover, 30559, Germany
Novartis Investigative Site
Haßfurt, 97437, Germany
Novartis Investigative Site
Haßloch, 67454, Germany
Novartis Investigative Site
Hohenstein-Ernstthal, 09337, Germany
Novartis Investigative Site
Jena, 07740, Germany
Novartis Investigative Site
Karlsruhe, 76135, Germany
Novartis Investigative Site
Kassel, 34121, Germany
Novartis Investigative Site
Köthen, 06366, Germany
Novartis Investigative Site
Lauchringen, 79787, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Ludwigshafen, 67063, Germany
Novartis Investigative Site
Magdeburg, 39114, Germany
Novartis Investigative Site
Magdeburg, 39120, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Mannheim, 68167, Germany
Novartis Investigative Site
Marl, 45768, Germany
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München, 80336, Germany
Novartis Investigative Site
München, 80636, Germany
Novartis Investigative Site
Münster, 48153, Germany
Novartis Investigative Site
Oldenburg, 26133, Germany
Novartis Investigative Site
Pressath, 92690, Germany
Novartis Investigative Site
Rostock, 18107, Germany
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Ulm, 89081, Germany
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Weinheim, 69469, Germany
Novartis Investigative Site
Wildeshausen, 27793, Germany
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Wolfratshausen, 82515, Germany
Novartis Investigative Site
Würzburg, 97080, Germany
Novartis Investigative Site
Alexandroupoli, Evros, 681 00, Greece
Novartis Investigative Site
Heraklion - Crete, Greece, 711 10, Greece
Novartis Investigative Site
Thesaloniki, Greece, 55134, Greece
Novartis Investigative Site
Athens, GR, 115 21, Greece
Novartis Investigative Site
Athens, GR, 115 25, Greece
Novartis Investigative Site
Athens, GR, 115 27, Greece
Novartis Investigative Site
Athens, GR, 14233, Greece
Novartis Investigative Site
Ioannina, GR, 451 10, Greece
Novartis Investigative Site
Larissa, GR, 411 10, Greece
Novartis Investigative Site
Thessaloniki, GR, 546 36, Greece
Novartis Investigative Site
Thessaloniki, GR, 56429, Greece
Novartis Investigative Site
Thessaloniki, GR, 570 10, Greece
Novartis Investigative Site
Tripoli, GR, 221 00, Greece
Novartis Investigative Site
Voula, GR, 166 73, Greece
Novartis Investigative Site
Athens, 106 76, Greece
Novartis Investigative Site
Athens, 115 21, Greece
Novartis Investigative Site
Athens, 115 26, Greece
Novartis Investigative Site
Athens, 115 27, Greece
Novartis Investigative Site
Athens, 115 28, Greece
Novartis Investigative Site
Athens, 11521, Greece
Novartis Investigative Site
Athens, 11526, Greece
Novartis Investigative Site
Athens, 11527, Greece
Novartis Investigative Site
Athens, 145 61, Greece
Novartis Investigative Site
Athens, 15127, Greece
Novartis Investigative Site
Athens, 15562, Greece
Novartis Investigative Site
Athens, 176 74, Greece
Novartis Investigative Site
Athens, GR14564, Greece
Novartis Investigative Site
Chaïdári, 12461, Greece
Novartis Investigative Site
Chios, 821 00, Greece
Novartis Investigative Site
Corfu, 49100, Greece
Novartis Investigative Site
Edessa, 58200, Greece
Novartis Investigative Site
Elefsina, 19600, Greece
Novartis Investigative Site
Glyfada, 16675, Greece
Novartis Investigative Site
Heraklion, 714 09, Greece
Novartis Investigative Site
Ioannina, 45001, Greece
Novartis Investigative Site
Kalamata, 241 00, Greece
Novartis Investigative Site
Karditsa, 43100, Greece
Novartis Investigative Site
Katerini, 601 00, Greece
Novartis Investigative Site
Kavala, 65 500, Greece
Novartis Investigative Site
Kilkis, 611 00, Greece
Novartis Investigative Site
Kozani, 50100, Greece
Novartis Investigative Site
Marousi, 15125, Greece
Novartis Investigative Site
Piraeus, 18454, Greece
Novartis Investigative Site
Piraeus, 185 36, Greece
Novartis Investigative Site
Rio Patra, 26504, Greece
Novartis Investigative Site
Thessaloniki, 54636, Greece
Novartis Investigative Site
Thessaloniki, 54642, Greece
Novartis Investigative Site
Thessaloniki, 552 36, Greece
Novartis Investigative Site
Volos, GR 38222, Greece
Novartis Investigative Site
Co Dublin, Ireland, Ireland
Novartis Investigative Site
Dublin, 9, Ireland
Novartis Investigative Site
Beirut, 11-2555, Lebanon
Novartis Investigative Site
Beirut, 1107 2020, Lebanon
Novartis Investigative Site
Beirut, 166378, Lebanon
Novartis Investigative Site
Beirut, 5544, Lebanon
Novartis Investigative Site
Beirut, 6301, Lebanon
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
El Achrafiyé, 166830, Lebanon
Novartis Investigative Site
Saida, 652, Lebanon
Novartis Investigative Site
Tripoli, Lebanon
Novartis Investigative Site
Msida, MSD 2090, Malta
Novartis Investigative Site
Panama City, Panama
Novartis Investigative Site
Manila, National Capital Region, 1000, Philippines
Novartis Investigative Site
Makati City, 1229, Philippines
Novartis Investigative Site
Manila, 1000, Philippines
Novartis Investigative Site
Ljubljana, 1000, Slovenia
Novartis Investigative Site
Córdoba, Andalusia, 14004, Spain
Novartis Investigative Site
Garanada, Andalusia, 18004, Spain
Novartis Investigative Site
Jerez de la Frontera, Andalusia, 11407, Spain
Novartis Investigative Site
Seville, Andalusia, 41014, Spain
Novartis Investigative Site
Utrera, Andalusia, 41710, Spain
Novartis Investigative Site
Baleares, Balearic Islands, 7014, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Novartis Investigative Site
Bilbao, Basque Country, 48013, Spain
Novartis Investigative Site
Galdakano, Basque Country, 48960, Spain
Novartis Investigative Site
Villamartín, Cadiz, 11650, Spain
Novartis Investigative Site
Santander, Cantabria, 39008, Spain
Novartis Investigative Site
Torrelavega, Cantabria, 39300, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Lleida, Catalonia, 25198, Spain
Novartis Investigative Site
Salt, Catalonia, 17190, Spain
Novartis Investigative Site
Badajoz, Extremadura, 6011, Spain
Novartis Investigative Site
Pontevedra, Galicia, 36001, Spain
Novartis Investigative Site
Logroño, La Rioja, 26006, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de G.C, 35010, Spain
Novartis Investigative Site
Majadahonda, Madrid, 28222, Spain
Novartis Investigative Site
San Sebastián de los Reyes, Madrid, 28702, Spain
Novartis Investigative Site
San Sebastián de los Reyes, Madrid, 28703, Spain
Novartis Investigative Site
Marbella, Malaga, 29603, Spain
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
Badalona, 08911, Spain
Novartis Investigative Site
El Palmar (Murcia), 30120, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria, 35010, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria, 35016, Spain
Novartis Investigative Site
Madrid, 28023, Spain
Novartis Investigative Site
Madrid, 28031, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 28046, Spain
Novartis Investigative Site
Salamanca, 37007, Spain
Novartis Investigative Site
Seville, 41009, Spain
Novartis Investigative Site
Seville, 41010, Spain
Novartis Investigative Site
Zaragoza, 50009, Spain
Novartis Investigative Site
Zaragoza, 50015, Spain
Novartis Investigative Site
Lucerne, Canton of Lucerne, 6004, Switzerland
Novartis Investigative Site
Abu Dhabi, 51900, United Arab Emirates
Novartis Investigative Site
Ras al-Khaimah, 4727, United Arab Emirates
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Last Updated
February 15, 2021
Record last verified: 2021-02