NCT02661217

Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,002 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	LCZ696	LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food. The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.

Timeline

• Start date: 2016-02-12
• Primary completion: 2018-02-20
• Completion: 2018-06-20
• First posted: 2016-01-22
• Last updated: 2021-04-26
• Results posted: 2021-04-26

Locations

152 sites across 19 countries: Argentina, Belgium, Canada, Czechia, France, Germany, Italy, Lebanon, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study