Clinical trial NCT04587947: Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
Official title: Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Patients
Lead sponsor: St. Josefs-Hospital Wiesbaden GmbH
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Changes in heart rate variability
timeFrame: 24 months
measure: Changes in left ventricular ejection fraction (%)
timeFrame: 24 months
measure: Changes in mitral insufficiency grade
timeFrame: 24 months
measure: Changes in serum NT-proB-Type natriuretic peptide (ng/l)
timeFrame: 24 months
measure: Changes in Serum creatinine level (mg/dl)
timeFrame: 24 months
measure: Changes in glomerular filtration rate (ml/min)
timeFrame: 24 months
measure: Changes in serum potassium level (mmol/l)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden GmbH
Study officials:
References:
citation: Boehmer AA, Schubert T, Rothe M, Keim C, Wiedenmann L, Ruckes C, von Stuelpnagel L, Theurl F, Schreinlechner M, Dobre BC, Kaess BM, Bauer A, Ehrlich JR. Angiotensin Receptor-Neprilysin Inhibitor Is Associated With Improved Cardiac Autonomic Function in Heart Failure. J Am Heart Assoc. 2024 Aug 6;13(15):e033538. doi: 10.1161/JAHA.123.033538. Epub 2024 Jul 31.