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Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06532825
Acronym
CADYSH
Enrollment
200
Registered
2024-08-01
Start date
2024-08-01
Completion date
2025-12-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, decompensated

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.

Interventions

DIAGNOSTIC_TESTheart monitoring

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

Sponsors

University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of rehospitalizationsup to six months after discharge from index admissionnumber of emergency rehospitalizations, classified according to: 1. new decompensation of heart failure 2. side effects / complications to therapy for heart failure 3. other

Secondary

MeasureTime frameDescription
Heart rate Variability change from admission to dischargerepeated 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

MeasureTime frameDescription
Diastolic functionsix monthsMeasurement of changes diastolic function in right and left ventricle based on wavelet-ECG measurements

Countries

Denmark

Contacts

Primary ContactHelena Dominguez
mdom0002@regionh.dk22989343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026