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

Not Applicable

Completed

• Conditions: Heart Failure Patients

• Registration Number: NCT04587947
• Lead Sponsor: St. Josefs-Hospital Wiesbaden GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular ejection fraction (%)	24 months	Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
Changes in heart rate variability	24 months	Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
Changes in mitral insufficiency grade	24 months	Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
Changes in serum NT-proB-Type natriuretic peptide (ng/l)	24 months	Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
Changes in Serum creatinine level (mg/dl)	24 months	Changes in laboratory parameters (Serum creatinine level (mg/dl)
Changes in glomerular filtration rate (ml/min)	24 months	Changes in laboratory parameters (glomerular filtration rate ml/min)
Changes in serum potassium level (mmol/l)	24 months	Changes in laboratory parameters (glomerular filtration rate ml/min)

Trial Locations

Locations (1)

St. Josefs-Hospital Wiesbaden GmbH; 🇩🇪 Wiesbaden, Germany