Heart Failure Clinical Trial

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Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

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Summary

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria:

Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

498

Study ID:

NCT01922089

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 105 Locations for this study

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Novartis Investigative Site
Anchorage Alaska, 99508, United States
Novartis Investigative Site
Gilbert Arizona, 85297, United States
Novartis Investigative Site
Tucson Arizona, 85710, United States
Novartis Investigative Site
Anaheim California, 92801, United States
Novartis Investigative Site
Torrance California, 90502, United States
Novartis Investigative Site
Atlantis Florida, 33462, United States
Novartis Investigative Site
Chiefland Florida, 32626, United States
Novartis Investigative Site
Aurora Illinois, 60504, United States
Novartis Investigative Site
Peoria Illinois, 61602, United States
Novartis Investigative Site
Evansville Indiana, 47714, United States
Novartis Investigative Site
Slidell Louisiana, 70458, United States
Novartis Investigative Site
Minneapolis Minnesota, 55417, United States
Novartis Investigative Site
St. Louis Missouri, 63110, United States
Novartis Investigative Site
Buffalo New York, 14215, United States
Novartis Investigative Site
Laurelton New York, 11422, United States
Novartis Investigative Site
Marion Ohio, 43302, United States
Novartis Investigative Site
Oak Ridge Tennessee, 37830, United States
Novartis Investigative Site
Dallas Texas, 75231, United States
Novartis Investigative Site
Houston Texas, 77030, United States
Novartis Investigative Site
Houston Texas, 77094, United States
Novartis Investigative Site
Livingston Texas, 77351, United States
Novartis Investigative Site
Tacoma Washington, 98405, United States
Novartis Investigative Site
Gabrovo , 5300, Bulgaria
Novartis Investigative Site
Plovdiv , 4000, Bulgaria
Novartis Investigative Site
Plovdiv , 4004, Bulgaria
Novartis Investigative Site
Smolian , 4700, Bulgaria
Novartis Investigative Site
Sofia , 1202, Bulgaria
Novartis Investigative Site
Sofia , 1407, Bulgaria
Novartis Investigative Site
Jyvaskyla , 40620, Finland
Novartis Investigative Site
Tampere , 33520, Finland
Novartis Investigative Site
Bad Krozingen , 79189, Germany
Novartis Investigative Site
Berlin-Buch , 13125, Germany
Novartis Investigative Site
Berlin , 10367, Germany
Novartis Investigative Site
Berlin , 10787, Germany
Novartis Investigative Site
Berlin , 10789, Germany
Novartis Investigative Site
Berlin , 13055, Germany
Novartis Investigative Site
Berlin , 13347, Germany
Novartis Investigative Site
Berlin , 13353, Germany
Novartis Investigative Site
Berlin , 13405, Germany
Novartis Investigative Site
Dietzenbach , 63128, Germany
Novartis Investigative Site
Ebersbach , 02730, Germany
Novartis Investigative Site
Frankfurt , 60594, Germany
Novartis Investigative Site
Göttingen , D-370, Germany
Novartis Investigative Site
Hassloch , 67454, Germany
Novartis Investigative Site
Huy / OT Anderbeck , 38836, Germany
Novartis Investigative Site
Ingelheim , 55218, Germany
Novartis Investigative Site
Kelkheim , 65779, Germany
Novartis Investigative Site
Kleve , 47533, Germany
Novartis Investigative Site
Leipzig , 04315, Germany
Novartis Investigative Site
Mainz , 55116, Germany
Novartis Investigative Site
Mainz , 55131, Germany
Novartis Investigative Site
Mühlheim , 45468, Germany
Novartis Investigative Site
Siegen , 57072, Germany
Novartis Investigative Site
Straubing , 94315, Germany
Novartis Investigative Site
Wuerzburg , 97078, Germany
Novartis Investigative Site
Budapest , 1042, Hungary
Novartis Investigative Site
Budapest , 1145, Hungary
Novartis Investigative Site
Budapest , H-109, Hungary
Novartis Investigative Site
Debrecen , 4032, Hungary
Novartis Investigative Site
Mosonmagyarovar , 9200, Hungary
Novartis Investigative Site
Nyiregyháza , 4400, Hungary
Novartis Investigative Site
Pecs , 7623, Hungary
Novartis Investigative Site
Szekesfehervar , 8000, Hungary
Novartis Investigative Site
Aosta AO, 11100, Italy
Novartis Investigative Site
Cortona AR, 52044, Italy
Novartis Investigative Site
Bergamo BG, 24128, Italy
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Cona FE, 44100, Italy
Novartis Investigative Site
Albano Laziale RM, 00041, Italy
Novartis Investigative Site
Roma RM, 00163, Italy
Novartis Investigative Site
Sassari SS, 07100, Italy
Novartis Investigative Site
Vittorio Veneto TV, 31029, Italy
Novartis Investigative Site
San Daniele Del Friuli UD, 33038, Italy
Novartis Investigative Site
San Juan , 00936, Puerto Rico
Novartis Investigative Site
Brezno Slovak Republic, 977 4, Slovakia
Novartis Investigative Site
Nitra Slovak Republic, 949 0, Slovakia
Novartis Investigative Site
Svidnik Slovak Republic, 08901, Slovakia
Novartis Investigative Site
Bratislava , 821 0, Slovakia
Novartis Investigative Site
Bratislava , 83301, Slovakia
Novartis Investigative Site
Kosice , 040 0, Slovakia
Novartis Investigative Site
Lucenec , 98439, Slovakia
Novartis Investigative Site
Nove Zamky , 940 0, Slovakia
Novartis Investigative Site
Trebisov , 075 0, Slovakia
Novartis Investigative Site
Almeria Andalucia, 04120, Spain
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Sanlucar de Barrameda Andalucia, 11540, Spain
Novartis Investigative Site
Sevilla Andalucia, 41014, Spain
Novartis Investigative Site
Villamartin Cadiz, 11650, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
A Coruna Galicia, 15006, Spain
Novartis Investigative Site
Madrid , 28007, Spain
Novartis Investigative Site
Haydarpasa/Istanbul , 34668, Turkey
Novartis Investigative Site
Istanbul , 34304, Turkey
Novartis Investigative Site
Kocaeli , 41380, Turkey
Novartis Investigative Site
Mersin , 33079, Turkey
Novartis Investigative Site
Sivas , 58140, Turkey
Novartis Investigative Site
Dorchester Dorset, DT1 2, United Kingdom
Novartis Investigative Site
St Leonards on Sea East Sussex, TN37 , United Kingdom
Novartis Investigative Site
Oldham Lancashire, OL1 2, United Kingdom
Novartis Investigative Site
Gateshead Tyne and Wear, NE9 6, United Kingdom
Novartis Investigative Site
Bath , BA1 3, United Kingdom
Novartis Investigative Site
Bradford , BD9 6, United Kingdom
Novartis Investigative Site
Coventry , CV2 2, United Kingdom
Novartis Investigative Site
Harrow , HA1 3, United Kingdom
Novartis Investigative Site
Nuneaton , CV10 , United Kingdom
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How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

498

Study ID:

NCT01922089

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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