Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001343190
Ethics application status
Approved
Date submitted
17/09/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Factors Influencing Exercise Tolerance in Patients with Atrial Fibrillation
Scientific title
Factors Influencing Exercise Tolerance in Patients with Atrial Fibrillation
Secondary ID [1] 299386 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 314457 0
Condition category
Condition code
Cardiovascular 312792 312792 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study, we will evaluate the influence of pre-specified anthropometric variables (height, body mass index), resting echocardiographic measures (Left Ventricular (LV) systolic function, LV diastolic function, LV diameter, Right Ventricular systolic function and left atrial volume) and comorbidities (type II diabetes, hypertension, obstructive sleep apnea) on peak oxygen uptake, assessed during cardiopulmonary exercise testing, amongst a cohort of paroxysmal and persistent atrial fibrillation patients. Study participants will undergo a cardiopulmonary exercise test (CPET, 8-15 minutes), resting transthoracic echocardiogram, clinical review and will undertake a atrial fibrillation specific symptom questionnaire (AFSS, Atrial Fibrillation Symptom Severity Questionnaire). CPET will involves walking on a treadmill at a fixed speed (default 5.3 km/h, tailored to the individual), with gradient increasing 1% per minute. All measures will be obtained within a 2 week period. There is no ongoing follow-up as part of this study.
Intervention code [1] 315587 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321414 0
Peak oxygen uptake, recording using a metabolic cart during cardiopulmonary exercise treadmill testing. Peak oxygen uptake is determined by the highest 20s averaged oxygen uptake prior to exhaustion.
Timepoint [1] 321414 0
Study Entry
Secondary outcome [1] 374908 0
Ventilatory Efficiency, assessed using the slope of the relationship between minute ventilation and carbon dioxide production during cardiopulmonary exercise testing with a metabolic cart.
Timepoint [1] 374908 0
Study Entry

Eligibility
Key inclusion criteria
Paroxysmal or Persistent Atrial Fibrillation
Aged 30-80 years
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Reduced Left Ventricular Ejection Fraction <50%
Moderate to Severe Valvular DIsease
Malignancy
Recent Cardiac Surgery (<12 months)
Recent Myocardial Infarction (<12 months)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Multivariable regression to assess influence of 15 factors, selected a priori, on the primary and secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
5/04/2019
Date of last data collection
Anticipated
Actual
12/04/2019
Sample size
Target
200
Accrual to date
Final
203
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 303839 0
University
Name [1] 303839 0
Centre for Heart Rhythm Disorders, University of Adelaide
Country [1] 303839 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide
SA, 5005
Country
Australia
Secondary sponsor category [1] 303971 0
None
Name [1] 303971 0
Address [1] 303971 0
Country [1] 303971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304354 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 304354 0
Ethics committee country [1] 304354 0
Australia
Date submitted for ethics approval [1] 304354 0
Approval date [1] 304354 0
27/03/2015
Ethics approval number [1] 304354 0

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

Contacts
Principal investigator
Name 96658 0
Dr Adrian Elliott
Address 96658 0
Centre for Heart Rhythm Disorders
University of Adelaide
North Terrace
Adelaide
SA 5005
Country 96658 0
Australia
Phone 96658 0
+61 8 8313 9000
Fax 96658 0
Email 96658 0
[email protected]
Contact person for public queries
Name 96659 0
Adrian Elliott
Address 96659 0
Centre for Heart Rhythm Disorders
University of Adelaide
North Terrace
Adelaide
SA 5005
Country 96659 0
Australia
Phone 96659 0
+61 8 8313 9000
Fax 96659 0
Email 96659 0
[email protected]
Contact person for scientific queries
Name 96660 0
Adrian Elliott
Address 96660 0
Centre for Heart Rhythm Disorders
University of Adelaide
North Terrace
Adelaide
SA 5005
Country 96660 0
Australia
Phone 96660 0
+61 8 8313 9000
Fax 96660 0
Email 96660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.