LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Heart Failure

In brief

The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.

Key facts

Study ID

NCT00887588

Run by

Novartis Pharmaceuticals

People needed

307

Starts

2009-11-01

Expected to finish

2011-12-01

Last updated by the study team

2015-08-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with documented stable chronic heart failure (NYHA II-IV):
• LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography)
• the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
• Plasma NT-proBNP > 500 pg/ml at Visit 1.
• Patients with documented stable chronic heart failure (NYHA II-IV).
• Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1.
• Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
• Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
• Patients with at least one of the following symptoms at the time of screening (Visit 1):
• Dyspnea on exertion
• Orthopnea
• Paroxysmal nocturnal dyspnea
• Peripheral edema
• Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
• Patients with a potassium ≤5.2 mmol/l at Visit 1.

You may not qualify if…

• Patients with a prior LVEF reading <45%, at any time.
• Patients who require treatment with both an ACE inhibitor and an ARB.
• Isolated right heart failure due to pulmonary disease.
• Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity.
• Presence of hemodynamically significant mitral and /or aortic valve disease.
• Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
• Presence of hypertrophic obstructive cardiomyopathy.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Grand Island, Nebraska, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Tulsa, Oklahoma, United States
• Novartis Investigative Site — Hillsboro, Oregon, United States
• Novartis Investigative Site — Wyomissing, Pennsylvania, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Ciudad Autonoma de Bs As, Buenos Aires, Argentina
• Novartis Investigative Site — Ramos Mejía, Buenos Aires, Argentina
• Novartis Investigative Site — San Martín, Buenos Aires, Argentina
• Novartis Investigative Site — Corrientes, Corrientes Province, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — Santa Fe, Santa Fe Province, Argentina
• Novartis Investigative Site — Santa Fe, Santa Fe Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — Goiânia, Goiás, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — São José do Rio Preto, São Paulo, Brazil
• Novartis Investigative Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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