Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:3/7/2019
Start Date:July 18, 2014
End Date:May 31, 2019

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A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the
reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF
with preserved ejection fraction.


Inclusion Criteria:

- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or
within 6 months prior to study entry.

- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at
least 30 days prior to study entry.

- Current symptom(s) of HF

- Structural heart disease (left atrial enlargement or left ventricular hypertrophy)
documented by echocardiogram.

- Elevated NT-proBNP

Exclusion Criteria:

- Any prior measurement of LVEF < 40%.

- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within
3 months , or urgent percutaneous coronary intervention within 3 months or and
elective PCI within 30 days prior to entry.

- Any clinical event within the 6 months prior to entry could have reduced the LVEF
(e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF
≥45%.

- Current acute decompensated HF requiring therapy.

- Patients who require treatment with 2 or more of the following: an angiotensin
converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin
inhibitor.

- Alternative reason for shortness of breath such as: significant pulmonary disease or
severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.

- Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at
entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110
mmHg at entry.

Other protocol-defined inclusion/exclusion criteria may apply.
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