NCT04587947

Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing sacubitril/ valsartan in Heart Failure Patients in 63 participants. Completed in 31 May 2022.

Timeline

1 April 2020

Primary endpoint
31 May 2022

31 May 2022

Quick facts

Lead sponsor	St. Josefs-Hospital Wiesbaden GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	1 April 2020
Primary completion	31 May 2022
Estimated completion	31 May 2022
Sites	1 location across Germany

Drugs / interventions tested

• sacubitril/ valsartan

Conditions studied

• Heart Failure Patients — all drugs for Heart Failure Patients →

Sponsor

St. Josefs-Hospital Wiesbaden GmbH

Who can join

Adults 20 to 99, any sex, with Heart Failure Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators.

Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death.

In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization.

Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modern Approaches for the Treatment of Heart Failure: Recent Advances and Future Perspectives.
   Popa IP, Haba MȘC, Mărănducă MA, Tănase DM, et al · · 2022 · cited 11× · PMID 36145711 · DOI 10.3390/pharmaceutics14091964
2. Angiotensin Receptor-Neprilysin Inhibitor Is Associated With Improved Cardiac Autonomic Function in Heart Failure.
   Boehmer AA, Schubert T, Rothe M, Keim C, et al · · 2024 · cited 4× · PMID 39082399 · DOI 10.1161/jaha.123.033538