NCT03005184

Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study tests the hypothesis that endogenous bradykinin contributes to effects of a combined angiotensin receptor blocker/neprilysin inhibitor (LCZ696 or Entresto)

Detailed description

Patients with heart failure (HF) with reduced ejection fraction who qualify for the study will undergo a three-week run-in period in which any prior angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker they were taking will be discontinued and they will be given valsartan 80 mg bid in a single-blind fashion. After the run-in, subjects will undergo four study periods in random order. During two study periods they will receive enalapril 10 mg bid and during two they will receive sacubitril/valsartan (LCZ696) 200 mg bid for seven days. On the seventh day or each period, subjects will complete a study day in which they are randomized to receive either the bradykinin B2 receptor blocker icatibant or placebo intravenously. Each study period will be separated by a three-week washout during which subjects receive valsartan 80 mg bid.

Conditions

• Heart Failure NYHA Class I
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Interventions

Type	Name	Description
DRUG	Valsartan 80 mg bid	oral medication during run-in and washout period
DRUG	Enalapril 10 mg bid	oral medication
DRUG	Sacubitril-Valsartan 200 mg bid	oral medication
DRUG	Icatibant	intravenous medication
DRUG	Placebo	intravenous medication

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-12-29
• Last updated: 2018-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study