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.

Phase 2

Completed

• Conditions: chronic heart failure; 10019280

• Registration Number: NL-OMON35586
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

See protocol for complete criteria (page 21 -22)
2) Male or female outpatients, * 40 years of age
3) Patients with documented stable chronic heart failure (NYHA II - IV) and:
- LVEF * 45% (local measurement, within the past 6 months or after any event that would effect ejection fraction)
- Plasma NT-proBNP > 400 pg/ml at Visit 1
- Patients must be on diuretic therapy prior to Visit 1 (flexible dose permitted)
4) Patients with at least one of the following symptoms at visit 1:
- Dyspnea on exertion
- Orthopnea
- Paroxysmal nocturnal dyspnea
- Peripheral edema

Exclusion Criteria

See protocol for complete criteria pages 22-24
1) Patients with a prior LVEF reading <45%, at any time
2) Patient who require treatment with both an ACE inhibitor and an ARB
3) Isolated right heart failure due to pulmonary disease
4) Dyspnea and/ore edema from non-cardiac causes, such as lung disease, anemia, or severe obesity
7) Presence of hypertrophic obstructive cardiomyopathy
8) Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infiltrative cardiomyopathy
12) History of MI, unstable angina, coronary bypass surgery or any PCI, stroke or TIA during the past 3 months prior to visit 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate the efficacy of LCZ696 in patients with chronic heart failure<br /><br>with preserved ejection fraction (HF-PEF) by testing the hypothesis that the<br /><br>reduction in NT-proBNP with LCZ696 is greater that that with valsartan after 12<br /><br>weeks of treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate LCZ696, compared to valsartan on the following parameters:<br /><br>- BNP, MR-pro-ANP and cGMP<br /><br>- echocardiographic parameters of diastolic function<br /><br>- improvement in signs and symptoms of heart failure, changes in quality of<br /><br>life assessments (assessed by total score and individual scores of the<br /><br>sub-domains from the KCCQ) and changes in clinical composite score<br /><br>- major adverse cardiovasular events<br /><br>- renal function; eGFR, serum creatinine, proteinuria change<br /><br>- vascular arterial stiffness, in a subset of patients<br /><br>- changes in blood pressure<br /><br>- safety and tolerability</p><br>