Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure (CADYSH)

February 22, 2025 updated by: Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg
The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

If the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six months.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Cardiology department Y, Bispebjerg-Frederiksberg Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted to the hospital with acute decompensated heart failure, regardless of measured left ventricle ejection fraction.

Patients will be grouped according to rhythm: sinus rhythm and atrial fibrillation.

Description

Inclusion Criteria:

  • 18-years age or older
  • admitted with acute decompensated heart failure for less than 48 h

Exclusion Criteria:

  • pacemaker
  • not signed informed consent
  • other heart rhythm than sinus rhythm or atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of rehospitalizations
Time Frame: up to six months after discharge from index admission

number of emergency rehospitalizations, classified according to:

  1. new decompensation of heart failure
  2. side effects / complications to therapy for heart failure
  3. other
up to six months after discharge from index admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate Variability change from admission to discharge
Time Frame: repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)

Measurement of heart-rate oscillations over a short term (30 min) of continuous three-lead electrocardiogram recording divided into two time domains:

Domain 10min: relaxed, supine position for 10 min Domain 30 min: comprising the first 10 min-domain in addition to stand-up and walking for 5 min, followed by sitting relaxed until completing 30 min recording in total
repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic function
Time Frame: six months
Measurement of changes diastolic function in right and left ventricle based on wavelet-ECG measurements
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24002374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe