Conditions: Chronic Heart Failure
Keywords: Chronic heart failure preserved ejection fraction cardiovascular disease NT-proBNP biomarkers Heart failure with preserved left-ventricular ejection fraction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 307
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. arm 2: During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.

Interventions: intervention 1: LCZ696 intervention 2: Valsartan intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg, 100 mg and 200 mg tablets intervention 2: 40 mg, 80 mg and 160 mg tablets intervention 3: matching placebo to LCZ696 and Valsartan

Protocol document: