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Trial registered on ANZCTR


Registration number
ACTRN12614001123639
Ethics application status
Approved
Date submitted
26/06/2014
Date registered
23/10/2014
Date last updated
18/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-Term Effect of Goal directed weight management on Atrial Fibrillation Cohort: A 5 Year follow-up study
Scientific title
Evaluating the impact of a weight loss on the burden of Atrial fibrillation ( AF) in obese patients
Secondary ID [1] 284763 0
nil
Universal Trial Number (UTN)
Trial acronym
LEGACY Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation burden 292134 0
obesity 292391 0
Condition category
Condition code
Cardiovascular 292467 292467 0 0
Other cardiovascular diseases
Diet and Nutrition 292709 292709 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Weight loss - self directed or through weight loss clinic. Diet included any type of caloric restriction, and exercise included any type of exercise in which it was possible to quantify the recommended activity.

According to recent AHA/ACC guidelines for the management of obesity in adults, any weight loss >3% is considered meaningful reduction and compared from weight loss <3% or weight gain group. To determine the dose response effect of weight loss (WL), groups were divided into Group-1 (>10% WL), Group-2 (3-9% WL) and Group-3 (<3% WL or weight gain).

For the purpose of these analyses, weight fluctuation (WF) was defined a priori as at least a 2% weight cycle (“Gain and loss” or “loss and gain”). For the assessment of the effect of WF we have divided the patients into Wide (>5% WF) Average (2-5% WF) and stable (<2% WF) during the yearly follow up for 5 years.

Intervention code [1] 289558 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292331 0
Reduction in AF burden as assessed by 7 days Holter study and AF symptom severity score (AFSS)
Timepoint [1] 292331 0
Long term follow up with annual follow up until five years
Secondary outcome [1] 308724 0
AF symptom burden (AF frequency, duration and symptom burden) assessed by AF Symptom Severity score (AFSS)
AF burden will be assessed by clinic ECG, 7 days Holter and device checks.
AF symptom severity will be assessed using previously validated and used AF based questionnaire.(AFSS Questionnaire.
Timepoint [1] 308724 0
Patients were followed up annually for 5 years
AF burden will be assessed by clinic ECG, 7 days Holter and device checks.
AF symptom severity will be assessed using previously validated and used AF based questionnaire.(AFSS Questionnaire.
Secondary outcome [2] 309419 0
Impact of weight fluctuation on AF burden and long term freedom from AF.
For the purpose of these analyses, weight fluctuation (WF) is defined a priori as at least a 2% weight cycle (“Gain and loss” or “loss and gain”). For the assessment of the effect of WF we have divided the patients into Wide (>5% WF) Average (2-5% WF) and stable (<2% WF) during the yearly follow up of 5 years.
Timepoint [2] 309419 0
Long term follow up with annual follow up for 5 years
Patients were followed up annually for 5 years
AF burden will be assessed by clinic ECG, 7 days Holter and device checks.
AF symptom severity will be assessed using previously validated and used AF based questionnaire.(AFSS Questionnaire.
Secondary outcome [3] 309420 0
Cardiorespiratory fitness (CRF), in sex specific metabolic equivalents (METs), was estimated from a symptom-limited maximal treadmill exercise test (EST) using standard Bruce protocol at baseline and final follow up. Peak heart rate (HR) and HR after 3 minutes into recovery was recorded during the exercise test from the attached monitor.
These outcomes will be assessed at baseline and final follow up of the patient.
Timepoint [3] 309420 0
This outcome will be assessed at baseline and final follow up at five years.

Eligibility
Key inclusion criteria
Age: 18 – 85 years
paroxysmal or persistent AF
Paroxysmal AF defined as recurrent episodes that self-terminate within 7 days or persistent AF as recurrent episodes that last more than 7 days and may be terminated with cardioversion.
Stable or no coronary artery disease.
Risk Factors identified at initial assessment including obesity (BMI>27), hypertension, diabetes, smoking and ETOH abuse.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cardiac valvulopathy
Significant left ventricular systolic dysfunction (EF less than or equal than 45% on Simpson biplane estimation or regional wall motion abnormalities), obvious LV regional wall motion abnormality, dilated LV
Myocardial infraction or cardiac surgery in the previous 12 months, and previous ablation for AF
Right ventricular dysfunction with or without pulmonary hypertension (resting PASP equal to 45mmHg) and/or at least moderate tricuspid regurgitation
Congenital heart disease
Severe coronary heart disease.
Uncontrolled endocrinopathy (adrenal, thyroid, etc.)
Severe medical condition such as malignancies, autoimmune or inflammatory diseases, renal failure, or hepatic failure

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2610 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8284 0
5000 - Halifax Street

Funding & Sponsors
Funding source category [1] 289380 0
University
Name [1] 289380 0
Centre of Heart rhythm disorders
University of Adelaide
Address [1] 289380 0
University of adelaide, Adelaide,South Australia, 5000
Country [1] 289380 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
University of adelaide, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 288066 0
Hospital
Name [1] 288066 0
Royal Adelaide Hospital
Address [1] 288066 0
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia
5000
Country [1] 288066 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
It remains unclear whether obesity itself or its accompanying co-morbidities are causative in the development of the favourable substrate for atrial fibrillation. The exact mechanisms remain the subject of current research. There is preliminary data suggesting a reversal of this substrate following interventional weight loss strategies. Intensive weight reduction strategies may play a role in reversing the adverse electromechanical substrate and thus complementing concurrent therapies, pharmacotherapy or catheter-based.
In this observational clinical study, we propose to evaluate the effects of weight loss on the substrate predisposing to AF (clinically collected maps) and arrhythmia burden (during routine follow up).
Trial website
Trial related presentations / publications
Pathak RK, Middeldorp ME, Meredith M et al. Long-Term Effect of Goal-Directed Weight Management in an Atrial Fibrillation Cohort: A Long-Term Follow-Up Study (LEGACY). J Am Coll Cardiol 2015;65:2159-69.
Public notes

Contacts
Principal investigator
Name 47870 0
Prof PRASHANTHAN SANDERS
Address 47870 0
Centre for Heart Rhythm Disorders, University of Adelaide
Cardiovascular Investigation Unit, Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000 Australia
Country 47870 0
Australia
Phone 47870 0
+61 8 8222 2723
Fax 47870 0
Email 47870 0
Prash.Sanders@adelaide.edu.au
Contact person for public queries
Name 47871 0
Dr RAJEEV KUMAR PATHAK
Address 47871 0
Centre for Heart Rhythm Disorders, University of Adelaide
Cardiovascular Investigation Unit, Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000 Australia
Country 47871 0
Australia
Phone 47871 0
+61 8 8222 2723
Fax 47871 0
Email 47871 0
Rajeev.Pathak@adelaide.edu.au
Contact person for scientific queries
Name 47872 0
Dr RAJEEV KUMAR PATHAK
Address 47872 0
Centre for Heart Rhythm Disorders, University of Adelaide
Cardiovascular Investigation Unit, Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000 Australia
Country 47872 0
Australia
Phone 47872 0
+61 8 8222 2723
Fax 47872 0
Email 47872 0
Rajeev.Pathak@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary