Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000497000
Ethics application status
Approved
Date submitted
12/06/2010
Date registered
16/06/2010
Date last updated
2/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight management and Atrial Fibrillation: The impact of weight and risk factor management on AF burden in overweight and obese patients.
Scientific title
Impact of a weight and risk factor management program in overweight and obese patients, on atrial fibrillation burden.
Secondary ID [1] 251997 0
090817
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257561 0
Atrial arrhythmias 257562 0
Condition category
Condition code
Diet and Nutrition 257718 257718 0 0
Obesity
Cardiovascular 257719 257719 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Weight Management and Atrial Fibrillation is a multi-component prospective study aimed at investigating multiple research questions pertinent to obesity and atrial fibrillation:
1. The impact of weight and risk factor management on AF burden in overweight and obese patients
2. The impact of weight reduction prior to AF catheter ablation on procedure outcomes, in overweight and obese patients
3. The impact of weight reduction on the AF substrate and autonomic system modulation in overweight and obese patients: A mechanistic study (separate registration)

Weight Management and Atrial Fibrillation: The impact of weight and risk factor management on AF burden in overweight and obese patients.
Patients in the intervention group undergo a 2 phase physician-led weight management program concurrently with tight metabolic risk factor control.
Upon randomization to the intervention arm, patients undergo a 2 month modified very low calorie diet (VLCD) and a gradually titrated low intensity exercise program.
During the high intensity modified VLCD phase, patients will be prescribed a standard nutritionally complete meal replacement product (Prima Health Solutions, Kickstart) for 2 of the 3 daily meals. This will be ongoing for 2 months and used in conjunction with a didactic eating plan framework. Generally, patients will be prescribed an eating plan focusing on:
1. Calorie maintenance 800-1200 calories/day
2. Low glycemic index foods
3. High mono and poly unsaturated fats based foods
4. Low saturated fats, cholesterol and sodium based foods
5. Alcohol reduction (less than or equal to 30g/week)
Patients will be required to maintain a lifestyle journal outlining:
1. Exercise (duration and type)
2. Food intake (quantity and type)
3. Blood pressure measurements
Physical activity prescription is tailored as follows:
1. Initially 3 x 20 minute sessions of low intensity exercise per week (usually walking)
2. This is titrated upwards over the initial 2 months to 1 – 2 low intensity session(s) plus 1 – 2 moderate intensity session(s) per week. Moderate intensity sessions include, jogging, brisk walking, swimming, cross-trainer, rowing machine, cycling
3. In the case of limiting musculoskeletal conditions, hydrotherapy or aqua aerobics are utilized instead
4. Patients are encouraged to utilize pedometers to quantify their personal best and to aim to supersede this over time
At commencement, they are issued with pre-specified written material on healthy eating, dining out, food shopping and physical activity. During the initial phase of the program, patients will be reviewed monthly in a specialized weight and risk factor management clinic along with their lifestyle journal. Following the 2 month high intensity phase, patients will undergo a more gradual weight management program with greater focus on permanent lifestyle change. During the second phase of the study, meal replacement sachets will be discontinued. Patients will be reviewed 3 monthly in the clinic for the remaining duration of follow-up (15-months).
At baseline, weight, body mass index (BMI), waist circumference (WC), height, blood pressure as well as baseline demographic data are recorded. Patients have blood drawn for baseline fasting biochemistry (BUN, LFTs, INR, hsCRP, TSH, T4, Insulin, Glucose, Cholesterol, HDL, LDL and triglycerides). All patients undergo stringent risk factor identification and management. In addition to weight, metabolic risk factors include:
1. Smoking
2. Hyperlipidemia
3. Hypertension
4. Glucose intolerance or diabetes mellitus
5. Alcohol intake
6. Obstructive sleep apnea
All patients undergo sleep apnea screening through overnight polysommnography at a dedicated sleep unit. When clinically indicated (in conjunction with AHI interpretation), CPAP may be prescribed and titrated.
Patients are educated about tobacco and alcohol harm and provided with written education. Follow-up and feedback is provided on clinic visits. Alcohol reduction to less than or equal to 30g/week is aimed for, in view of established metabolic disease and cardiac arrhythmia.
In the event of intermediate fasting glycemia, a 2 hour glucose tolerance test is undertaken. If glucose intolerant or insulin resistant continued lifestyle measures are pursued. Patients with frank diabetes are prescribed oral hypoglycemic agents and referred to a diabetes clinic.
Hypertension is diagnosed based on family physician records and documented readings in the lifestyle journal. Management with a combination of lifestyle measures, salt reduction and pharmacotherapy is undertaken. Medication may be combined and titrated based on clinician judgment and patient tolerance.
During the follow-up visits, patients will undergo face-to-face counseling and feedback based on anthropometric measures and lifestyle journal. Patients will have access to 24 hour email and telephone support in addition to additional counseling sessions if required. At each appointment, data is entered into the OBEMAN software program.
Periodic measurements include:
1. BMI, WC, blood pressure, 12-lead ECG (baseline and three monthly)
2. Anti-hypertensive and anti-arrhythmic medication usage (baseline and three monthly)
3. Atrial Fibrillation Severity Scale (AFSS) (baseline and 3, 9, 12 and 15 months)
4. 7 day Holter recording (baseline and 15 months)
5. Transthoracic echocardiography (baseline and 15 months)
6. Cardiac MRI (baseline and 15 months)
7. Fasting plasma biochemistry (baseline and 15 months)
Weight Management and Atrial Fibrillation: The impact of weight reduction and risk factor management prior to AF catheter ablation on procedure outcomes, in overweight and obese patients.
The aim of this sub-study is to determine the impact of weight and risk factor management prior to catheter ablation on procedure outcomes, in overweight and obese subjects.
Patients who have undergone weight and risk factor modification and are clinical candidates for catheter ablation are recruited into this arm of the study.
Patients undergo the weight and risk factor management program as per the protocol in the sub-study, “Weight Management and Atrial Fibrillation: The impact of weight and risk factor management on AF burden in overweight and obese patients” (above). Patients who attain either end-point:
1. BMI < 27 and/or WC < 100cm (males) [<90cm (females)]
2. 15 month follow-up
Patients who remain symptomatic of AF are eligible to undergo a catheter ablation. Following the catheter ablation procedure, patients continue to undergo weight and risk factor management with three monthly follow-up for 24 months post procedure. The recurrence of AF post ablation is determined on follow-up.
Periodic measurements following catheter ablation include:
1. BMI, WC, blood pressure, 12-lead ECG (baseline and three monthly following procedure, for 24 months)
2. Anti-hypertensive and anti-arrhythmic medication usage (baseline and three monthly following procedure, for 24 months)
3. Atrial Fibrillation Severity Scale (AFSS) (three monthly following procedure, for 24 months)
4. 7 day Holter recording (baseline and 24 months)
5. Transthoracic echocardiography (baseline and 24 months)
6. Cardiac MRI (baseline and 24 months)
7. Fasting plasma biochemistry (baseline and 24 months)

Weight Management and Atrial Fibrillation: The impact of weight reduction on the AF substrate and autonomic system modulation in overweight and obese patients: A mechanistic study.
This study will be registered separately. It is mentioned briefly outlined here due to its overlapping nature and common steering committee.
The aim of this sub-study is to investigate the changes in the autonomic system and arrhythmogenic substrate with weight reduction, and the effect this has on AF burden.
Patients who have undergone weight and risk factor modification as per protocol for the sub-study, “Weight Management and Atrial Fibrillation: The impact of weight and risk factor management on AF burden in overweight and obese patients” (above), are eligible for entry into this sub-study.
The aim of this sub-study is to determine the changes in autonomic tone and AF substrate with weight and risk factor management.
The periodicity of follow-up data recording is as follows:
1. BMI, WC, blood pressure, 12-lead ECG (baseline and three monthly)
2. Anti-hypertensive and anti-arrhythmic medication usage (baseline and three monthly)
3. Atrial Fibrillation Severity Scale (AFSS) (baseline and 3, 9, 12 and 15 months)
4. 7 day Holter recording (baseline and 15 months)
5. Heart rate variability (baseline and 15 months)
6. Exercise stress testing (baseline and 15 months)
7. Head up tilt table testing (baseline and 15 months)
8. Transthoracic echocardiography (baseline and 15 months)
9. Delayed enhancement Cardiac MRI (baseline and 15 months)
10. Fasting plasma biochemistry (baseline and 15 months)

Control/comparator group:
Standard care is provided for the control group. This consists of:
1. Written material and verbal advice through direct contact counseling
2. 3g/day of marine omega triglycerides (docosahexaenoic acid and eicosapenteanoic acid)
3. Scheduled 3 monthly clinic visits
As for the intervention arm, patients are required to maintain a lifestyle journal which is reviewed three monthly. Diet and exercise counseling is provided via written material as a once-off session at commencement of participation.
Risk factors identification, management and data recording is carried out as per the intervention group.
Intervention code [1] 256646 0
Prevention
Intervention code [2] 256647 0
Treatment: Surgery
Intervention code [3] 256648 0
Diagnosis / Prognosis
Intervention code [4] 284904 0
Lifestyle
Comparator / control treatment
Standard care is provided for the control group. This consists of:
1. Written material and verbal advice through direct contact counseling
2. 3g/day of marine omega triglycerides (docosahexaenoic acid and eicosapenteanoic acid)
3. Scheduled 3 monthly clinic visits
As for the intervention arm, patients are required to maintain a lifestyle journal which is reviewed three monthly. Diet and exercise counseling is provided via written material as a once-off session at commencement of participation.
Risk factors identification, management and data recording is carried out as per the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 258620 0
Atrial arrhythmia burden and freedom from atrial fibrillation. Requirement for an ablation procedure or relapse into AF following an ablation. This is done using validated AF-specific questonnaires, Holter monitoring and 12 lead- electrocardiograph (ECG) recordings.
Timepoint [1] 258620 0
Baseline, 3, 6, 9, 12 and 15 month follow-up
Primary outcome [2] 258621 0
Cardiac structure and function on echocardiography and doppler echocardiography.
Timepoint [2] 258621 0
Baseline and 15 months
Secondary outcome [1] 264529 0
Atrial ectopy burden. This will be assessed by continuous 7-day Holter monitoring.
Timepoint [1] 264529 0
Baseline 15 months and 24 months.
Secondary outcome [2] 264556 0
Non-invasive and invasive assessment of the atrial arrhythmic substrate. Atrial voltage maps and conduction velocity.
Timepoint [2] 264556 0
Baseline only, according to body mass index.
Secondary outcome [3] 297557 0
Serum fasting biochemistry
Timepoint [3] 297557 0
Baseline and follow-up (15 months)
Secondary outcome [4] 297558 0
Cardiac structure and function. Delayed-enhancement atrial scar burden. This will be performed using cardiac magnetic resonance imaging (CMR) with delayed contrast enhancement.
Timepoint [4] 297558 0
Baseline and 15 months.

Eligibility
Key inclusion criteria
Inclusion criteria were: symptomatic paroxysmal or persistent AF; BMI (kgm-1)>27; waist circumference (cm) >100 (male) or >90 (females); and age 21-75 years.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent, significant (moderate-severe) valvular heart disease, moderate-severe left ventricular systolic dysfunction/moderate-severe cardiomyopathy, renal impairment, significant gastrointestinal/mal-absorptive disorder, vitamin and trace element deficiency, insulin-dependent diabetes mellitus, uncontrolled underlying significant medical condition, unstable INR, significant endocrinopathy and recent participation (3 months) in a structured weight loss program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment using unscreened referral of all subjects meeting above inclusion criteria. Allocation involved contacting the holder of the allocation schedule who was "off site"or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization between 0 (control) and 1 (active) using an electronic random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Follow-up at 15 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2990 0
5000
Recruitment postcode(s) [2] 2991 0
5117
Recruitment postcode(s) [3] 2992 0
5012
Recruitment postcode(s) [4] 2993 0
5009
Recruitment postcode(s) [5] 2994 0
5014
Recruitment postcode(s) [6] 2995 0
5154
Recruitment postcode(s) [7] 2996 0
5100
Recruitment postcode(s) [8] 2997 0
5200
Recruitment postcode(s) [9] 2998 0
5300
Recruitment postcode(s) [10] 2999 0
5400
Recruitment postcode(s) [11] 3000 0
5500

Funding & Sponsors
Funding source category [1] 257130 0
University
Name [1] 257130 0
The university of Adelaide
Country [1] 257130 0
Australia
Funding source category [2] 257131 0
Hospital
Name [2] 257131 0
The Royal Adelaide Hospital
Country [2] 257131 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University ofAdelaide
north Terrace, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 256388 0
Hospital
Name [1] 256388 0
The Royal Adelaide Hospital
Address [1] 256388 0
The Royal Adelaide Hospital
North Terrace, Adelaide, SA, 5000
Country [1] 256388 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259169 0
The Royal Adelaide Hospital, Research Ethics Committee
Ethics committee address [1] 259169 0
Ethics committee country [1] 259169 0
Australia
Date submitted for ethics approval [1] 259169 0
01/08/2009
Approval date [1] 259169 0
27/10/2009
Ethics approval number [1] 259169 0
090817a

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31283 0
Address 31283 0
Country 31283 0
Phone 31283 0
Fax 31283 0
Email 31283 0
Contact person for public queries
Name 14530 0
Professor Prash Sanders
Address 14530 0
Cardiovascular Research Centre.
Level 5 McEwin Building
The Royal Adelaide Hospital
North Terrace, Adelaide, SA, 5000
Country 14530 0
Australia
Phone 14530 0
+61 8 82222723
Fax 14530 0
+61 8 82222722
Email 14530 0
[email protected]
Contact person for scientific queries
Name 5458 0
Dr. Hany Abed
Address 5458 0
Cardiovascular Research Centre.
Level 5 McEwin Building
The Royal Adelaide Hospital
North Terrace, Adelaide, SA, 5000
Country 5458 0
Australia
Phone 5458 0
+61 8 82222723
Fax 5458 0
+61 8 82222722
Email 5458 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNon-invasive characterisation of electrical remodeling in an interventional weight loss program: Implications for obesity and atrial arrhythmias.2011https://dx.doi.org/10.1016/j.hlc.2011.05.256
EmbaseImpact of weight reduction on pericardial adipose tissue and cardiac structure in patients with atrial fibrillation.2015https://dx.doi.org/10.1016/j.ahj.2015.02.008
N.B. These documents automatically identified may not have been verified by the study sponsor.