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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Josefs-Hospital Wiesbaden GmbH | Wiesbaden | 65189 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39082399 | Result | 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. |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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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.
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