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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04587947
Other study ID # Entresto
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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