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

Sponsor
St. Josefs-Hospital Wiesbaden GmbH (Other)
Overall Status
Completed
CT.gov ID
NCT04587947
Collaborator
(none)
63
Enrollment
1
Location
26
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: sacubitril/ valsartan
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
May 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Changes in heart rate variability [24 months]

    Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan

  2. Changes in left ventricular ejection fraction (%) [24 months]

    Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)

  3. Changes in mitral insufficiency grade [24 months]

    Changes in mitral insufficiency grade assessed by transthoracic echocardiogram

  4. Changes in serum NT-proB-Type natriuretic peptide (ng/l) [24 months]

    Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)

  5. Changes in Serum creatinine level (mg/dl) [24 months]

    Changes in laboratory parameters (Serum creatinine level (mg/dl)

  6. Changes in glomerular filtration rate (ml/min) [24 months]

    Changes in laboratory parameters (glomerular filtration rate ml/min)

  7. Changes in serum potassium level (mmol/l) [24 months]

    Changes in laboratory parameters (glomerular filtration rate ml/min)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Josefs-Hospital Wiesbaden GmbH Wiesbaden Germany 65189

Sponsors and Collaborators

  • St. Josefs-Hospital Wiesbaden GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Josefs-Hospital Wiesbaden GmbH
ClinicalTrials.gov Identifier:
NCT04587947
Other Study ID Numbers:
  • Entresto
First Posted:
Oct 14, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Valsartan
Sacubitril and valsartan sodium hydrate drug combination

Study Results

No Results Posted as of Jun 21, 2022