A Study of the Effectiveness and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients with Preserved Ejection Fraction

Overview

About this study

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 who have HF with preserved ejection fraction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Left ventricular ejection fraction (LVEF) ≥45% prior to study entry
  • Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF ≥30 days prior to study entry
  • Current symptom(s) of HF
  • Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram
  • At least one of the following
    • A HF hospitalization within 9 months prior to study entry
    • An elevated NT-proBNP

Exclusion Criteria

  • Any prior measurement of LVEF < 45%
  • Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 30 days of entry
  • Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry 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) 
    • A renin inhibitor
  • Alternative reason for shortness of breath such as
    • Significant pulmonary disease or severe COPD
    • Hemoglobin (Hgb) <10 g/dl
    • 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
  • Other protocol-defined inclusion/exclusion criteria may apply

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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