NCT03415906

Influences of Angiotensin-neprilysin Inhibition on Sympathetic Activity in Heart Failure

Influences of Angiotensin-neprilysin Inhibition With Sacubitril/Valsartan (ENTRESTO®) on Centrally Generated Sympathetic Activity in Heart Failure Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The autonomic nervous system plays an important role in controlling the circulation. Increased sympathetic activity has detrimental effects in patients with heart failure. The purpose of this study is to test the hypothesis that combined angiotensin receptor + neprilysin inhibition results in lower sympathetic activity than angiotensin receptor inhibition alone.

Detailed description

Thirty-five heart-failure patients will be included in a prospective, monocentric, active-controlled, double-blind, cross-over study with randomized sequence of treatments sacubitril+valsartan or valsartan alone. After open-label dose finding and washout patients will be randomly assigned to the treatment sequence \[sac+val --\> val\] or \[val --\> sac+val\]. The two treatment periods of 4 weeks duration will be separated by 2 weeks of washout. At the end of both treatments the state of the cardiovascular system and its control will be measured.

Conditions

• Heart Failure

Interventions

Type	Name	Description
COMBINATION_PRODUCT	sacubitril+valsartan	Combined angiotensin receptor + neprilysin inhibition
DRUG	valsartan	Angiotensin receptor inhibition alone

Timeline

• Start date: 2017-12-14
• Primary completion: 2018-09-06
• Completion: 2018-09-06
• First posted: 2018-01-30
• Last updated: 2018-10-09

Locations

1 site across 1 country: Germany