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

Heart Failure Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587947
• Other study ID #: Entresto
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: St. Josefs-Hospital Wiesbaden GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Patients

Intervention

Drug:
• sacubitril/ valsartan
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

Locations

Country	Name	City	State
Germany	St. Josefs-Hospital Wiesbaden GmbH	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
St. Josefs-Hospital Wiesbaden GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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