Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation (ISOLATE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT02219841
First received: July 31, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Obesity
Procedure: radiofrequency catheter ablation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Arrhythmia recurrence [ Time Frame: 1 year post-ablation ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Weight loss following calorie-controlled diet and monitored exercise for 15 months 93 months pre-ablation + 12-months post-ablation)


Estimated Enrollment: 50
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No intervention group
Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib
Procedure: radiofrequency catheter ablation
Other Name: RFCA
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
Procedure: radiofrequency catheter ablation
Other Name: RFCA

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:

  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 exercise capacity It will be examined at baseline and 6 and 12 months post procedure in all patients utilizing cardiopulmonary exercise tests (CPX) with Vmax Encore equipment from Care Fusion, CA, USA.

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 before 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of 50 consecutive AF patients with BMI 26-40, will be enrolled in this pilot study and randomized to 2 groups in a 1:1 design (25 per group).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219841

Contacts
Contact: Mitra Mohanty, MD MS FHRS 5127842651 mitra1989@gmail.com
Contact: Tamara Metz, RN 512-544-8176 Tamara.Metz@stdavids.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center Not yet recruiting
Austin, Texas, United States, 78705
Contact: Mitra Mohanty, MD MS FHRS    512-544-8198    mitra.mohanty@stdavids.com   
Contact: Tamara Metz, RN    512-544-8176    Tamara.Metz@stdavids.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Mitra Mohanty, MD UT Austin
  More Information

No publications provided

Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT02219841     History of Changes
Other Study ID Numbers: TCAI_ISOLATE
Study First Received: July 31, 2014
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
Obesity, low-calorie diet, exercise, catheter ablation, atrial fibrillation

Additional relevant MeSH terms:
Obesity
Atrial Fibrillation
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014