Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 12:26 PM
Study NCT ID:
NCT03415906
Status:
WITHDRAWN
Last Update Posted:
2018-10-09
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influences of Angiotensin-neprilysin Inhibition on Sympathetic Activity in Heart Failure
Sponsor:
Hannover Medical School
Organization:
Study Overview
Official Title:
Influences of Angiotensin-neprilysin Inhibition With Sacubitril/Valsartan (ENTRESTO®) on Centrally Generated Sympathetic Activity in Heart Failure Patients
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties in recruiting patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARNI-Sy
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: