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Trial registered on ANZCTR
Registration number
ACTRN12624000938505p
Ethics application status
Not yet submitted
Date submitted
11/07/2024
Date registered
2/08/2024
Date last updated
2/08/2024
Date data sharing statement initially provided
2/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The STUNNED Heart study- a randomised study to see if patients with early recovery of heart function after a heart attack still need to take medications that improve heart function
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Scientific title
Randomized study evaluating effects of rationalizing medication in those who have stunning of the heart due to a heart attack
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Secondary ID [1]
312510
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome
334376
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low left venticular ejection fraction
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polypharmacy
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Condition category
Condition code
Cardiovascular
331016
331016
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Those who have recovered left ventricular ejection fraction (LVEF)> or = 50% at 2 -3 weeks post discharge (n=90) are randomised in 2:1 randomisation fashion to: stopping medications other than angiotensin converting enzyme inhibitors (ACEi)i/ angiotensin receptor blocker (ARB ) if indicated by a cardiologist . The intervention group will comprise 2/3 of patients and control group 1/3.. Down titration will be done according to local practice , but likely not necessary in most as patients will have been started medication 2 weeks previously.. adherence to study intervention will be from prescription records online.
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Intervention code [1]
329027
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Treatment: Drugs
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Comparator / control treatment
continuing standard treatment with heart failure medications . Current practice is to up titrate the pillars of heart health (entresto,sodium glucose like transporter 2(SGLT2 )inhibitor, beta blocker, spironolactone) as blood pressure and heart rate allows by cardiology nurse specialists
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in Left ventricular ejection fraction
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Assessment method [1]
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3-D assessment on echocardiogram
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Timepoint [1]
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at 3 months post initial echocardiogram done at baseline( 2 weeks post acute myocardial infarction (AMI)
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Secondary outcome [1]
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change in Global longitudinal strain (GLS)
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Assessment method [1]
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3-D echocardiogram
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Timepoint [1]
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at 3 months post baseline (2 weeks post acute coronary syndrome)
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Secondary outcome [2]
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change in left ventricular ejection fraction
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Assessment method [2]
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3-D echocardiogram
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Timepoint [2]
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at 12 months post baseline (2 weeks post acute coronary syndrome)
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Eligibility
Key inclusion criteria
1. Age >18 years of age
2. Able to give informed consent
3. LVEF <40% post type 1 AMI who have recovered to >50% at week 2 echo
4. Revascularised by percutaneous coronary intervention (PCI) during admission
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Minimum age
19
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. previous known cardiomyopathy
2. Atrial fibrillation
3. Clinical heart failure at time of MI or since discharge
4. Significant mitral or aortic valve disease
5. Planned staged percutaneous intervention (PCI)/coronary artery bypass graft (CABG)
6. LVEF>41% at baseline echocardiogram
7. LVEF<50% at 2-week echocardiogram
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
no
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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
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Bio-equivalence
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2024
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Actual
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Date of last participant enrolment
Anticipated
31/08/2026
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Actual
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Date of last data collection
Anticipated
31/08/2027
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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auckland
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Country [2]
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New Zealand
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State/province [2]
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Greenlane Research and Educational Fund
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Hospital
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Name
Auckland City Hospital
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319176
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Country [1]
319176
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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22/08/2024
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Approval date [1]
315684
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Ethics approval number [1]
315684
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Summary
Brief summary
Patients have echocardiograms within 1-2 days of a heart attack. Those with low heart function are started on multiple medications for heart failure based on chronic heart failure studies. However, for half, this is temporary stunning of the heart muscle that will spontaneously resolve within 2 weeks. Therefore, many patients are discharged and up titrated on drugs that may not be necessary. When an echocardiogram shows full recovery months later, it is difficult to stop these drugs as it is not known if they led to improvement in heart function. In this study, a repeat echocardiogram is done at 2 weeks, and if normal, participants will be randomised to continuing or stopping current heart failure medications. A repeat echocardiogram is done at 3 and 6 months to assess heart function. The aim of this is to see if we should be reassessing heart function before initiating lifelong multiple medications.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jocelyne Benatar
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Address
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Cardiology Dept, Auckland City Hospital Park rd,, Grafton, Auckland, New Zealand 1030
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Country
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New Zealand
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Phone
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+64 21893886
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jocelyne Benatar
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Address
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Cardiology Dept, Auckland City Hospital Park rd,, Grafton, Auckland, New Zealand 1030
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Country
135503
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New Zealand
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Phone
135503
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+64 21893886
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Fax
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Email
135503
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[email protected]
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Contact person for scientific queries
Name
135504
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Jocelyne Benatar
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Address
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Cardiology Dept, Auckland City Hospital Park rd,, Grafton, Auckland, New Zealand 1030
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Country
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New Zealand
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Phone
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+64 21893886
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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