Trial | NCT04587947  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    63
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.
Study Started
Apr 01
2020
Primary Completion
May 31
2022
Study Completion
May 31
2022
Last Update
Jun 21
2022

Drug sacubitril/ valsartan [sacubitril (Entresto), valsartan (diovan)]

Heart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment

Criteria 

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
No Results Posted