Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650995
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
AlEX-DHF Ablation and Exercise in Diastolic Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AlEX-DHF Ablation and Exercise in Diastolic Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AlEX-DHF
Brief Summary:
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
Exercise intervention will contain a 12-week combined video-based supervised endurance resistance and respiratory training
Detailed Description:
In a feasibility study the investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation and heart failure with preserved ejection fraction Patients will be randomized into 2 groups 1 A control group receiving ablation therapy and 2 a group receiving ablation therapy and a combination of endurance strength and respiratory training The investigators will include 20 patientsgroup All patients will receive a smart watch to monitor heart rate and trigger ECG recordings during symptomatic episodes Smart watch monitoring will be done for 4 weeks Then all patients will receive baseline examination with laboratory markers lung function testing echocardiography measurement of pulse wave velocity and screening for sleep apnea All patients will receive simultaneous cardiopulmonary exercise testing CPET and exercise right heart catheterization exRHC followed by ablation therapy Patients will then be randomized into a training and control group After 2 weeks all patients will receive outpatient CPET to assess changes of VO2peak compared to baseline
The training group will receive home-based video-supervised exercise training with a combination of endurance strength and respiratory training 5xweek The control group will receive standard recommendations on physical activity Smart watch monitoring will be continued in all groups until the end of the study After 12 weeks of training intervention all groups will undergo echocardiography lung function testing measurement of pulse wave velocity and exRHC with simultaneous CPET All patients will receive 24h Holter monitoring at the end of the study During exRHC lactate kinetics will be analyzed and improvement of lactate thresholds through exercise training will be determined The primary outcome is the improvement of VO2peak in the groups Secondary outcomes are improvements in the ratio of pulmonary capillary wedge pressurecardiac output PAWPCO and mean pulmonary artery pressureCO mPAPCO Burden of atrial fibrillation in the groups will also be assessed All groups will receive optimal drug therapy
The investigators expect that a combined approach of ablation and exercise training will better improve VO2peak through central ablation and peripheral exercise training adaptations
The training group will receive home-based video-supervised exercise training with a combination of endurance strength and respiratory training 5xweek The control group will receive standard recommendations on physical activity Smart watch monitoring will be continued in all groups until the end of the study After 12 weeks of training intervention all groups will undergo echocardiography lung function testing measurement of pulse wave velocity and exRHC with simultaneous CPET All patients will receive 24h Holter monitoring at the end of the study During exRHC lactate kinetics will be analyzed and improvement of lactate thresholds through exercise training will be determined The primary outcome is the improvement of VO2peak in the groups Secondary outcomes are improvements in the ratio of pulmonary capillary wedge pressurecardiac output PAWPCO and mean pulmonary artery pressureCO mPAPCO Burden of atrial fibrillation in the groups will also be assessed All groups will receive optimal drug therapy
The investigators expect that a combined approach of ablation and exercise training will better improve VO2peak through central ablation and peripheral exercise training adaptations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None