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Completed

NCT Number: NCT04587947

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

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.

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Key information

Conditions

Heart Failure Patients

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Changes in heart rate variability

    Time frame: 24 months

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

  2. 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)

  3. Changes in mitral insufficiency grade

    Time frame: 24 months

    Changes in mitral insufficiency grade assessed by transthoracic echocardiogram

  4. 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)

  5. Changes in Serum creatinine level (mg/dl)

    Time frame: 24 months

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

  6. Changes in glomerular filtration rate (ml/min)

    Time frame: 24 months

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

  7. Changes in serum potassium level (mmol/l)

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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