Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
Status: | Recruiting |
---|---|
Conditions: | Atrial Fibrillation, Obesity Weight Loss |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 10/21/2017 |
Start Date: | August 2014 |
End Date: | December 2019 |
Contact: | Mitra Mohanty, MD MS FHRS |
Email: | mitra1989@gmail.com |
Phone: | 5127842651 |
This prospective randomized pilot study aims to evaluate the impact of aggressive life style
modification in terms of calorie-controlled diet and supervised exercise on outcome of
catheter ablation in overweight and obese patients with atrial fibrillation.
Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen
improves the chances of freedom from recurrence following catheter ablation.
modification in terms of calorie-controlled diet and supervised exercise on outcome of
catheter ablation in overweight and obese patients with atrial fibrillation.
Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen
improves the chances of freedom from recurrence following catheter ablation.
Objective: To examine the impact of a planned life-style modification program including
calorie-controlled diet and supervised exercise before and after the AF ablation on quality
of life (QoL) and long-term arrhythmia recurrence in overweight and obese patients with
atrial fibrillation.
Endpoints:
Primary: AF recurrence following index ablation procedure It will be assessed at 3, 6 and 12
months after the procedure by event recorders, 12-lead ECG and Holter monitoring Any episode
of AF/AFL/AT > 30 sec will be considered as a recurrence. Episodes that occur during the
first 3 months after the procedure (blanking period) will not be considered as recurrence.
Secondary:
1. Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at
baseline and 6 and 12 months post-procedure
2. Change in AF symptom severity. This will be measured by AF symptom severity and burden
questionnaire at baseline and 6 and 12 months post-procedure
DIET:
Participants in the intervention group will receive individual counseling sessions with an
experienced dietitian, who will prepare personalized diet plan based on their comorbidities
and preferences.
To accomplish weight loss, the diet menu will be planned to reduce daily food intake by ≥ 500
calories depending on their baseline body weight.
Patients enrolled in the control group will be provided advice on heart-healthy diet and
active life style.
EXERCISE:
Supervised and monitored exercise will be conducted in St. David's Cardiac Rehabilitation for
3 months starting before or 7-10 days after the ablation.
After ablation, patients will continue individualized home-exercise program for 1 year.
QoL Survey:
The AF Effect on Quality of Life survey (AFEQT) questionnaire will be used at baseline and 6
and 12 months post procedure.
Symptom Severity Survey:
This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and
12 months post-procedure
calorie-controlled diet and supervised exercise before and after the AF ablation on quality
of life (QoL) and long-term arrhythmia recurrence in overweight and obese patients with
atrial fibrillation.
Endpoints:
Primary: AF recurrence following index ablation procedure It will be assessed at 3, 6 and 12
months after the procedure by event recorders, 12-lead ECG and Holter monitoring Any episode
of AF/AFL/AT > 30 sec will be considered as a recurrence. Episodes that occur during the
first 3 months after the procedure (blanking period) will not be considered as recurrence.
Secondary:
1. Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at
baseline and 6 and 12 months post-procedure
2. Change in AF symptom severity. This will be measured by AF symptom severity and burden
questionnaire at baseline and 6 and 12 months post-procedure
DIET:
Participants in the intervention group will receive individual counseling sessions with an
experienced dietitian, who will prepare personalized diet plan based on their comorbidities
and preferences.
To accomplish weight loss, the diet menu will be planned to reduce daily food intake by ≥ 500
calories depending on their baseline body weight.
Patients enrolled in the control group will be provided advice on heart-healthy diet and
active life style.
EXERCISE:
Supervised and monitored exercise will be conducted in St. David's Cardiac Rehabilitation for
3 months starting before or 7-10 days after the ablation.
After ablation, patients will continue individualized home-exercise program for 1 year.
QoL Survey:
The AF Effect on Quality of Life survey (AFEQT) questionnaire will be used at baseline and 6
and 12 months post procedure.
Symptom Severity Survey:
This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and
12 months post-procedure
Inclusion Criteria:
1. Age: > 18 years
2. AF patient undergoing first catheter ablation, at least 3 months after the enrollment
3. BMI: ≥ 26-40
4. Willing to be compliant with the weight-reduction program
5. Willing to provide informed, written consent
Exclusion Criteria:
1. Chronic obstructive lung disease (COPD)
2. Participation in another weight loss program in < 3 months
3. Musculoskeletal conditions limiting exercise capacity
4. Insulin-dependent diabetes
5. Severe valvular heart disease or cardiomyopathy
6. Heavy drinking (>14 standard drinks/week for men and >7/ week for women)
7. Inability to provide informed consent
We found this trial at
1
site
Austin, Texas 78705
Phone: 512-544-8198
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