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

NCT04587947 | Completed

• 1 other identifier: Entresto
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure Patients

Outcome Measures

Primary Outcomes (7)

• Changes in heart rate variability

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

  24 months

• Changes in left ventricular ejection fraction (%)

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

  24 months

• Changes in mitral insufficiency grade

  Changes in mitral insufficiency grade assessed by transthoracic echocardiogram

  24 months

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

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

  24 months

• Changes in Serum creatinine level (mg/dl)

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

  24 months

• Changes in glomerular filtration rate (ml/min)

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

  24 months

• Changes in serum potassium level (mmol/l)

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

  24 months

Interventions

sacubitril/ valsartan DRUG

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

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Atrial fibrillation
• Pregnancy
• Lack of consent capacity
• Contraindications for a therapy with sacubitril/ valsartan

Sponsors & Collaborators

• St. Josefs-Hospital Wiesbaden GmbH: lead

Study Sites (1)

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

Location

Related Publications (1)

• 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.

  PMID: 39082399 RESULT

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: October 14, 2020
• Study Start: April 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

DE (1)