Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000271505p
Ethics application status
Not yet submitted
Date submitted
13/02/2024
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Risk factors for developing heart failure in people with obesity
Scientific title
Risk factors for developing heart failure in people with obesity
Secondary ID [1] 311529 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 332880 0
Obesity 333076 0
Condition category
Condition code
Cardiovascular 329599 329599 0 0
Other cardiovascular diseases
Diet and Nutrition 329926 329926 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
Participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF) will receive a cardiac MRI and have telephone follow-up 6-monthly for 3 years to observe changes in weight, symptoms, instances and frequency of hospitalizations, and any instances of death.
The patients will have one in-person visit for CMR and baseline data. Follow-up will be a phone call at 6-monthly intervals for 3 years. If a participant dies during this time their data will be linked with the National Death Index.
Intervention code [1] 327984 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337383 0
Presence of myocardial fibrosis on cardiac MRI.
Timepoint [1] 337383 0
Baseline assessment only - early prevention/screening study.
Primary outcome [2] 337543 0
Weight changes
Timepoint [2] 337543 0
6-monthly for 3 years
Primary outcome [3] 337693 0
Presence of myocardial triglyceride
Timepoint [3] 337693 0
Baseline assessment only - early prevention/screening study.
Secondary outcome [1] 431633 0
Symptom progression on quality of life
Timepoint [1] 431633 0
6-monthly from baseline visit for a minimum of 3 years.
Secondary outcome [2] 432265 0
Frequency of hospitalizations
Timepoint [2] 432265 0
6-monthly for 3 years
Secondary outcome [3] 432266 0
Quality of life changes
Timepoint [3] 432266 0
6-monthly for 3 years
Secondary outcome [4] 432267 0
Sudden cardiac death
Timepoint [4] 432267 0
Death assessed for a maximum of 10 years post-enrolment

Eligibility
Key inclusion criteria
• Age 18-80 years
• Fluent in English
• Currently enrolled in the Alfred HFpEF clinic and have had an exercise RHC
• Experiencing breathlessness
• BMI >30kg/m2
• Eligible for Medicare (or equivalent health care insurance)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Type I or type II diabetes
• Prior heart failure diagnosis
• Pregnancy
• Contraindication to MRI (metallic implant, foreign body/device)

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
29/04/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26177 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42047 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315824 0
Other Collaborative groups
Name [1] 315824 0
Investigator Initiated - PI's Research Stipend
Country [1] 315824 0
Australia
Funding source category [2] 315827 0
Other Collaborative groups
Name [2] 315827 0
Baker Heart and Diabetes Institute
Country [2] 315827 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker Heart and Diabetes Institute
Address
Country
Australia
Secondary sponsor category [1] 317955 0
None
Name [1] 317955 0
Address [1] 317955 0
Country [1] 317955 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314680 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314680 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314680 0
Australia
Date submitted for ethics approval [1] 314680 0
01/04/2024
Approval date [1] 314680 0
Ethics approval number [1] 314680 0

Summary
Brief summary
Participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF) will undergo a cardiac MRI to see if any structural heart changes can be used to predict those who are high-risk for progression of disease. Weight changes, hospitalizations, and symptom will be tracked every 6-months for a minimum of 3 years, and linking data with the National Death Index will allow us to identify patterns between heart failure and cardiac-related death. This data will allow the implementation of screening with MRI and early intervention for high-risk groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132378 0
Dr Sarah Gutman
Address 132378 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 132378 0
Australia
Phone 132378 0
+610385321302
Fax 132378 0
Email 132378 0
sarah.gutman@baker.edu.au
Contact person for public queries
Name 132379 0
Eloise Thompson
Address 132379 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 132379 0
Australia
Phone 132379 0
+610385321862
Fax 132379 0
Email 132379 0
ethompson@baker.edu.au
Contact person for scientific queries
Name 132380 0
Eloise Thompson
Address 132380 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 132380 0
Australia
Phone 132380 0
+610385321862
Fax 132380 0
Email 132380 0
ethompson@baker.edu.au

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.