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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2022
  • participants needed
    50
  • sponsor
    St. Josefs-Hospital Wiesbaden GmbH
Updated on 26 January 2021

Summary

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.

Details
Condition Heart Failure Patients
Treatment sacubitril/ valsartan
Clinical Study IdentifierNCT04587947
SponsorSt. Josefs-Hospital Wiesbaden GmbH
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with symptomatic severe heart failure with reduced ejection fraction (LVEF 40%,)
Age > 20 years
Consent capacity
Sinus rhythm
Suitable for a drug conversion from AT1/ACE inhibitors to sacubitril/ valsartan

Exclusion Criteria

Age < 18 years
Atrial fibrillation
Pregnancy
Lack of consent capacity
Contraindications for a therapy with sacubitril/ valsartan
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