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

June 17, 2022 updated by: St. Josefs-Hospital Wiesbaden GmbH

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany, 65189
        • St. Josefs-Hospital Wiesbaden GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Josefs-Hospital Wiesbaden GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Entresto

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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