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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587947
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
St. Josefs-Hospital Wiesbaden GmbH

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.


Condition or disease Intervention/treatment Phase
Heart Failure Patients Drug: sacubitril/ valsartan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • 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


Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587947


Contacts
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Contact: Joachim Ehrlich, MD +496111771201 jehrlich@joho.de
Contact: Andreas Boehmer, MD +496111771201 aboehmer@joho.de

Locations
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Germany
St. Josefs-Hospital Wiesbaden GmbH Recruiting
Wiesbaden, Germany, 65189
Contact: Joachim Ehrlich, Prof. Dr.    +496111771201    jehrlich@joho.de   
Contact: Andreas Boehmer, Dr. med.    +496111771201    aboehmer@joho.de   
Sponsors and Collaborators
St. Josefs-Hospital Wiesbaden GmbH
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Responsible Party: St. Josefs-Hospital Wiesbaden GmbH
ClinicalTrials.gov Identifier: NCT04587947    
Other Study ID Numbers: Entresto
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action