LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2009 |
End Date: | December 2011 |
A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
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.
on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart
failure and preserved left-ventricular ejection fraction.
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
We found this trial at
12
sites
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