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

Completed · Phase 3

Conditions studied: Heart Failure With Preserved Ejection Fraction

In brief

The purpose of this study was 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.

Key facts

Study ID

NCT01920711

Run by

Novartis Pharmaceuticals

People needed

4822

Starts

2014-07-18

Expected to finish

2019-06-07

Last updated by the study team

2020-09-29

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (NYHA class II-IV)
• Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
• Elevated NT-proBNP

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Northridge, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Santa Ana, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Hartford, Connecticut, United States
• Novartis Investigative Site — New Haven, Connecticut, United States
• Novartis Investigative Site — Stamford, Connecticut, United States
• Novartis Investigative Site — West Haven, Connecticut, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Lake Worth, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Covington, Georgia, United States
• Novartis Investigative Site — Cumming, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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