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AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

ConditionsHFpEF - Heart Failure With Preserved Ejection FractionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTechnical University of Munich

About this trial

The investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). It is hypothesized that the combination of ablation and exercise better improves peak oxygen consumption (VO2peak) through improvement of peripheral (exercise training) and central (ablation) adaptations.

Exercise intervention will contain a 12-week combined, video-based, supervised, endurance, resistance and respiratory training.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed heart failure with preserved ejection fraction

Symptomatic short-persistent atrial fibrillation (diagnosis within 1 year of study inclusion)

Disqualifiers

Paroxysmal, long-persistent or permanent atrial fibrillation

Clinically unstable coronary artery disease or acute coronary syndrome

Physical and/or mental inability to perform exercise testing

Prior ablation therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise training

    Other intervention

    exercise intervention will consist of supervised, home-based, combined training with elements of endurance, resistance and respiratory training

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Delta of peak oxygen consumption

Improvement of peak oxygen consumption between baseline and after 12 weeks of training

Time frame
14 weeks

Secondary outcomes

1

Delta of mean pulmonary artery pressure and cardiac output (mPAP/CO)

Improvement of delta mPAP/CO between baseline and after 12 weeks of training

Time frame
14 weeks
2

Delta of pulmonary artery wedge pressure to cardiac output (PAWP/CO)

Improvement of delta PAWP/CO between baseline and after 12 weeks of training

Time frame
14 weeks
3

Delta of peak oxygen consumption baseline to post ablation

Improvement of peak oxygen consumption from baseline to post ablation

Time frame
2 weeks
4

Delta of peak oxygen consumption post ablation to the end of the study

Improvement of peak oxygen consumption from post ablation to the end of the study

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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Technical University of Munich

Lead sponsor

Source ClinicalTrials.gov
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