Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06532825
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-31
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Posted: 2024-08-01
• Last Update Submitted: 2025-02-22
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of rehospitalizations	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

Secondary Outcome Measures

Name	Time	Method
Heart rate Variability change from admission to discharge	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

Trial Locations

Locations (1)

Cardiology department Y, Bispebjerg-Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark