Heart Failure Patients
Conditions
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.
Interventions
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
Sponsors
St. Josefs-Hospital Wiesbaden GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in heart rate variability | 24 months | Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan |
| Changes in left ventricular ejection fraction (%) | 24 months | Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters) |
| Changes in mitral insufficiency grade | 24 months | Changes in mitral insufficiency grade assessed by transthoracic echocardiogram |
| Changes in serum NT-proB-Type natriuretic peptide (ng/l) | 24 months | Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l) |
| Changes in Serum creatinine level (mg/dl) | 24 months | Changes in laboratory parameters (Serum creatinine level (mg/dl) |
| Changes in glomerular filtration rate (ml/min) | 24 months | Changes in laboratory parameters (glomerular filtration rate ml/min) |
| Changes in serum potassium level (mmol/l) | 24 months | Changes in laboratory parameters (glomerular filtration rate ml/min) |
Countries
Germany
Outcome results
None listed