Study to compare Pre-discharge and Post-discharge treatment initiation with LCZ696 therapy in heart failure patients with reduced ejection fraction (HF-rEF) after an acute decompensation event

Phase 1

• Conditions: Heart Failure with reduced ejection fraction (HF-rEF) stabilized after hospitalization due to acute decompensated heart failure episode.; MedDRA version: 18.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003266-87-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- Patients hospitalized due to acute decompensated HF episode (ADHF)
- Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction
- Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to randomization
- Stabilized (while in the hospital) for at least 24 hours leading to randomization
- Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

- Symptomatic hypotension and/or a SBP < 110 mm Hg or SBP > 180 mm Hg prior to randomization
- End stage renal disease at screening; or estimated GFR < 30 mL/min/1.73 m2 as measured by (MDRD) formula at randomization.
- Serum potassium > 5.4 mmol/L at randomization.
- Current hospitalization where patient does not receive treatment for decompensated HF.
- Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
- Severe hepatic impairment, biliary cirrhosis and cholestasis
- Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified