Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000270516p
Ethics application status
Submitted, not yet approved
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
The effect of substantial weight loss with tirzepatide on heart failure with preserved ejection fraction in people with obesity
Scientific title
The effect of substantial weight loss with tirzepatide on heart failure with preserved ejection fraction in people with obesity
Secondary ID [1] 311534 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 332888 0
Obesity 333084 0
Condition category
Condition code
Cardiovascular 329603 329603 0 0
Other cardiovascular diseases
Diet and Nutrition 329925 329925 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will receive tirzepatide (Eli Lilly)- titrated as per manufacturer's guidelines until the maximum dose (or tolerated dose) of 15mg weekly subcutaneous injection for 12-months. Starting at 2.5mg weekly, increasing by 2.5mg increments every 4 weeks until the maximum dose (15mg) is achieved.
There are no laboratory tests that monitor adherence to this medication.
Intervention code [1] 327988 0
Treatment: Drugs
Comparator / control treatment
Comparator is a placebo of normal saline 0.9% which will be provided in identical vials to the study drug. Participants will be randomized to each group.
Control group
Placebo

Outcomes
Primary outcome [1] 337388 0
A change in the mean pulmonary artery pressure (MPAP) during exercise
Timepoint [1] 337388 0
Baseline and 12-months after treatment with study drug.
Secondary outcome [1] 431646 0
An change in functional exercise capacity.
Timepoint [1] 431646 0
Baseline and 12-months after treatment with the study drug
Secondary outcome [2] 431647 0
Change in myocardial triglyceride content
Timepoint [2] 431647 0
Baseline and 12-months after treatment with the study drug
Secondary outcome [3] 431648 0
Structural muscular changes
Timepoint [3] 431648 0
Baseline and 12-months after treatment with the study drug
Secondary outcome [4] 431649 0
Changes in cardiac biomarkers.
Timepoint [4] 431649 0
Baseline and 12-months after treatment with the study drug
Secondary outcome [5] 431650 0
Changes in quality of life
Timepoint [5] 431650 0
Baseline and 12-months after treatment with the study drug
Secondary outcome [6] 432303 0
Structural changes observed on echocardiogram
Timepoint [6] 432303 0
Baseline and 12-months following treatment with the study drug

Eligibility
Key inclusion criteria
• Are greater than 18 years old,
• Have a BMI of 30 or more, or a BMI of 27 or more and at least one weight-related complication (e.g., hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease),
• Report one or more unsuccessful dietary effort to lose weight.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diabetes
• Change in body weight of more than 5 kg within 90 days before screening
• Previous or planned surgical treatment for obesity
• Treatment with a medication that promotes weight loss within 90 days before screening
• Ejection fraction <50% (current or prior)
• Pregnancy
• Significant valvular heart disease (greater than mild stenosis, greater than moderate regurgitation)
• Pulmonary arterial hypertension
• Constrictive pericarditis
• Primary cardiomyopathies
• Heart transplantation
• Significant pulmonary disease
• History of pancreatitis
• Previous bariatric surgery
• Diagnosis of gastroparesis
• Diagnosis of cancer within the past 5 years (excluding skin cancers)
• Personal or family history of medullary thyroid cancer
• Patients not eligible for Medicare
• Patients who are not fluent in English.

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Using REDCap randomization tool.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
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
1/04/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26178 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42049 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315829 0
Self funded/Unfunded
Name [1] 315829 0
Investigator Initiated - PI's Research Stipend
Country [1] 315829 0
Australia
Funding source category [2] 315830 0
Other Collaborative groups
Name [2] 315830 0
Baker Heart and Diabetes Institute
Country [2] 315830 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker Heart and Diabetes Institute
Address
Country
Australia
Secondary sponsor category [1] 317958 0
None
Name [1] 317958 0
Address [1] 317958 0
Country [1] 317958 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314685 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314685 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314685 0
Australia
Date submitted for ethics approval [1] 314685 0
06/03/2024
Approval date [1] 314685 0
Ethics approval number [1] 314685 0

Summary
Brief summary
Diabetics on the study drug, tirzepatide, have been shown to experience significant weight loss during their treatment with this medication. Our study aims to identify its mechanism of action for patients with heart failure with preserved ejection fraction (HFpEF) and examine if treatment with this medication can significantly improve structural, functional, and symptomatic outcomes of patients with heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132394 0
Dr Sarah Gutman
Address 132394 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 132394 0
Australia
Phone 132394 0
+610385321302
Fax 132394 0
Email 132394 0
[email protected]
Contact person for public queries
Name 132395 0
Eloise Thompson
Address 132395 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 132395 0
Australia
Phone 132395 0
+61385321862
Fax 132395 0
Email 132395 0
[email protected]
Contact person for scientific queries
Name 132396 0
Eloise Thompson
Address 132396 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 132396 0
Australia
Phone 132396 0
+61385321862
Fax 132396 0
Email 132396 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.