Recruiting

Lifestyle Modification

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT02219841

Conditions

Atrial Fibrillation

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

radiofrequency catheter ablation

Study Details

Brief summary:

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.

Conditions

Atrial Fibrillation

Obesity

Study ID

NCT02219841

Start date

Aug, 2014

Status verified date

Sep, 2019

Completion date

Dec, 2022

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

No intervention group

Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib

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

Interventions

radiofrequency catheter ablation

Primary outcome measure

  • Arrhythmia recurrence [ Time Frame: 1 year post-ablation ]

Central Contacts and Locations

Central contacts

Mitra Mohanty, MD MS FHRS

5127842651mitra1989@gmail.com

Tamara Metz, RN

512-544-8176Tamara.Metz@stdavids.com

Locations

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Mitra Mohanty, MD MS FHRS

512-544-8198mitra.mohanty@stdavids.com

Tamara Metz, RN

512-544-8176Tamara.Metz@stdavids.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Sep 11, 2019

Last verified

Sep, 2019

Keywords

  • Obesity, low-calorie diet, exercise, atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2019-09-11.