Hemodynamic assessment in heart failure.
Christopher Charles Jain, Barry A Borlaug
https://pubmed.ncbi.nlm.nih.gov/31507065/Actively Recruiting
Led by Technical University of Munich · Updated on 2025-12-26
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are studying the effects of combining ablation therapy and exercise training in patients who have symptomatic short-persistent atrial fibrillation and heart failure with preserved ejection fraction HFpEF. The goal is to see if this combination improves peak oxygen consumption VO2peak by enhancing both central heart function through ablation and peripheral adaptations through exercise. This is a randomized, single-blind feasibility study including 40 patients divided into two groups. Participants will be assigned either to a control group receiving ablation therapy alone or to an experimental group receiving ablation therapy plus a 12-week home-based, video-supervised exercise program. The exercise program includes endurance, resistance, and respiratory training conducted five times per week. All patients will wear a smartwatch to monitor heart rate and record ECG during symptoms for 4 weeks initially and throughout the study. Baseline and follow-up assessments include laboratory tests, lung function, echocardiography, pulse wave velocity, sleep apnea screening, cardiopulmonary exercise testing combined with exercise right heart catheterization, and 24-hour Holter monitoring. Participants will undergo evaluations before and after ablation, with the second cardiopulmonary exercise test occurring 2 weeks post-ablation and the final assessments after 12 weeks of intervention. Researchers will measure changes in VO2peak as the primary outcome, along with secondary measures such as pulmonary artery pressure ratios, heart failure questionnaire scores, and atrial fibrillation burden. Optimal drug therapy will be maintained for all, and smartwatch monitoring will continue until study completion. The total study period for each participant is approximately 14 weeks, with ongoing safety and functional assessments.
CONDITIONS
AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure
M
Martin Halle, Professor
M
Manuel Rattka, MD
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Technical University of Munich
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive baseline examinations including laboratory markers, lung function testing, echocardiography, pulse wave velocity measurement, sleep apnea screening, cardiopulmonary exercise testing (CPET), and exercise right heart catheterization (exRHC).
1 visit (in-person)
Duration - 1 day
Participants undergo ablation therapy after baseline assessments.
1 visit (in-person)
Duration - 2 weeks
Two weeks after ablation, participants receive an outpatient CPET to assess changes in peak oxygen consumption (VO2peak) compared to baseline.
1 visit (outpatient)
Duration - 12 weeks
Participants are randomized into two groups: the training group receives home-based, video-supervised exercise training 5 times per week, and the control group receives standard physical activity recommendations. Smart watch monitoring continues for all participants during this period.
Weekly monitoring via smart watch; exercise training 5 times per week for training group
Duration - 1 day
After 12 weeks of intervention, participants undergo echocardiography, lung function testing, pulse wave velocity measurement, exercise right heart catheterization with simultaneous CPET, and 24-hour Holter monitoring to evaluate treatment effects.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Christopher Charles Jain, Barry A Borlaug
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https://pubmed.ncbi.nlm.nih.gov/36220507/Technical University of Munich
Lead Sponsor