Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-years age or older

admitted with acute decompensated heart failure for less than 48 h

Disqualifiers

pacemaker

not signed informed consent

other heart rhythm than sinus rhythm or atrial fibrillation

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • heart monitoring

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

number of rehospitalizations

number of emergency rehospitalizations, classified according to: 1. new decompensation of heart failure 2. side effects / complications to therapy for heart failure 3. other

Time frame
up to six months after discharge from index admission

Secondary outcomes

1

Heart rate Variability change from admission to discharge

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

Time frame
repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)

Other outcomes

1

Diastolic function

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

Time frame
six months

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