Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

NCT ID: NCT06532825

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

heart monitoring

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

heart rate variability

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Helena DOMINGUEZ

MD, PhD, Consultant, Assoc.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiology department Y, Bispebjerg-Frederiksberg Hospital

Frederiksberg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Helena Dominguez

Role: CONTACT

mdom0002@regionh.dk

22989343

Facility Contacts

Helena Dominguez, MD, PhD

Role: primary

mdom0002@regionh.dk

+4538163916 ext. 6068

Christoffer V Madsen, MD

Role: backup

cmad0140@regionh.dk

+4520661178

Other Identifiers

H-24002374

Identifier Type: -

Identifier Source: org_study_id