Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06532825

Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heart monitoring

Diagnostic Test

individual comparison of heart rate variability at admission with a repeated measurement before discharge

Other names: heart rate variability

Primary outcomes

  1. number of rehospitalizations

    Time frame: up to six months after discharge from index admission

    number of emergency rehospitalizations, classified according to:

    • new decompensation of heart failure
    • side effects / complications to therapy for heart failure
    • other

Secondary outcomes

  1. 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

Other outcomes

  1. Diastolic function

    Time frame: six months

    Measurement of changes diastolic function in right and left ventricle based on wavelet-ECG measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Dominguez

CONTACT

[email protected]

22989343

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Acronym: CADYSH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.