- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219841
Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation (ISOLATE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at baseline and 6 and 12 months post-procedure
- 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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mitra Mohanty, MD MS FHRS
- Phone Number: 5127842651
- Email: mitra1989@gmail.com
Study Contact Backup
- Name: Tamara Metz, RN
- Phone Number: 512-544-8176
- Email: Tamara.Metz@stdavids.com
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- Recruiting
- Texas Cardiac Arrhythmia Institute, St. david's Medical Center
-
Contact:
- Tamara Metz, RN
- Phone Number: 512-544-8176
- Email: Tamara.Metz@stdavids.com
-
Contact:
- Mitra Mohanty, MD MS FHRS
- Phone Number: 512-544-8198
- Email: mitra.mohanty@stdavids.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: > 18 years
- AF patient undergoing first catheter ablation, at least 3 months after the enrollment
- BMI: ≥ 26-40
- Willing to be compliant with the weight-reduction program
- Willing to provide informed, written consent
Exclusion Criteria:
- Chronic obstructive lung disease (COPD)
- Participation in another weight loss program in < 3 months
- Musculoskeletal conditions limiting exercise capacity
- Insulin-dependent diabetes
- Severe valvular heart disease or cardiomyopathy
- Heavy drinking (>14 standard drinks/week for men and >7/ week for women)
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No intervention group
Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib
|
Other Names:
|
Life-style intervention
patients will receive personilized low-calorie diet menu and undergo supervised exercise in the cardiac rehabilitation facility for 3 months before ablation with an aim of loosing >10% of body weight.
They will continue diet and exercise for 1 year following ablation procedure Will receive catheter ablation for AFib
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arrhythmia recurrence
Time Frame: 1 year post-ablation
|
Arrhythmia recurrence will be monitored at 3-month intervals with Holter monitor, event recorder, cardiology evaluation and ECG.
Recurrence is defined as any episode of AF/ atrial flutter/ atrial tachycardia of >30 seconds duration with or without anti-arrhythmic drugs, occurring after 3 months of blanking period following catheter ablation
|
1 year post-ablation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 1 year
|
The AF Effect on Quality of Life survey (AFEQT questionnaire will be used at baseline and 6 and 12 months post procedure.
It is a validated self-administered questionnaire of 20 questions for AF patients that evaluates health-related QoL across 3 domains; symptoms, daily activity and treatment concerns
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: 1 year
|
Weight loss following calorie-controlled diet and monitored exercise for 12 months
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mitra Mohanty, MD, Texas Cardiac Arrhythmia Institiute
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCAI_ISOLATE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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