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

Primary Purpose

Heart Failure Patients

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sacubitril/ valsartan
Sponsored by
St. Josefs-Hospital Wiesbaden GmbH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure Patients

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Josefs-Hospital Wiesbaden GmbH

Outcomes

Primary Outcome Measures

Changes in heart rate variability
Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
Changes in left ventricular ejection fraction (%)
Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
Changes in mitral insufficiency grade
Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
Changes in serum NT-proB-Type natriuretic peptide (ng/l)
Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
Changes in Serum creatinine level (mg/dl)
Changes in laboratory parameters (Serum creatinine level (mg/dl)
Changes in glomerular filtration rate (ml/min)
Changes in laboratory parameters (glomerular filtration rate ml/min)
Changes in serum potassium level (mmol/l)
Changes in laboratory parameters (glomerular filtration rate ml/min)

Secondary Outcome Measures

Full Information

First Posted
June 24, 2020
Last Updated
June 17, 2022
Sponsor
St. Josefs-Hospital Wiesbaden GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04587947
Brief Title
Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
Official Title
Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Josefs-Hospital Wiesbaden GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sacubitril/ valsartan
Intervention 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
Primary Outcome Measure Information:
Title
Changes in heart rate variability
Description
Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
Time Frame
24 months
Title
Changes in left ventricular ejection fraction (%)
Description
Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
Time Frame
24 months
Title
Changes in mitral insufficiency grade
Description
Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
Time Frame
24 months
Title
Changes in serum NT-proB-Type natriuretic peptide (ng/l)
Description
Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
Time Frame
24 months
Title
Changes in Serum creatinine level (mg/dl)
Description
Changes in laboratory parameters (Serum creatinine level (mg/dl)
Time Frame
24 months
Title
Changes in glomerular filtration rate (ml/min)
Description
Changes in laboratory parameters (glomerular filtration rate ml/min)
Time Frame
24 months
Title
Changes in serum potassium level (mmol/l)
Description
Changes in laboratory parameters (glomerular filtration rate ml/min)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Josefs-Hospital Wiesbaden GmbH
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany

12. IPD Sharing Statement

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

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