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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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