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

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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.


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
Tulsa, Oklahoma 74104
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Tulsa, OK
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Caba, Buenos Aires
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Caba,
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Chicago, Illinois 60612
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Chicago, IL
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Detroit, Michigan 48202
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Detroit, MI
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Grand Island, Nebraska 68803
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Grand Island, NE
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Hillsboro, Oregon 97123
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from
Hillsboro, OR
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Houston, Texas 77030
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Houston, TX
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Lincoln, Nebraska 68506
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from
Lincoln, NE
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Little Rock, Arkansas 72204
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from
Little Rock, AR
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Nashville, Tennessee 37205
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Nashville, TN
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Oklahoma City, Oklahoma 73104
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from
Oklahoma City, OK
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Wyomissing, Pennsylvania 19610
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from
Wyomissing, PA
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