Trial Review

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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
Scientific title
Randomized study evaluating effects of rationalizing medication in those who have stunning of the heart due to a heart attack
Secondary ID [1] 312510 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 334376 0
low left venticular ejection fraction 334377 0
polypharmacy 334378 0
Condition category
Condition code
Cardiovascular 331016 331016 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329027 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 338781 0
Change in Left ventricular ejection fraction
Timepoint [1] 338781 0
at 3 months post initial echocardiogram done at baseline( 2 weeks post acute myocardial infarction (AMI)
Secondary outcome [1] 437408 0
change in Global longitudinal strain (GLS)
Timepoint [1] 437408 0
at 3 months post baseline (2 weeks post acute coronary syndrome)
Secondary outcome [2] 437409 0
change in left ventricular ejection fraction
Timepoint [2] 437409 0
at 12 months post baseline (2 weeks post acute coronary syndrome)

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
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
no
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 26418 0
New Zealand
State/province [1] 26418 0
auckland
Country [2] 26476 0
New Zealand
State/province [2] 26476 0

Funding & Sponsors
Funding source category [1] 316934 0
Charities/Societies/Foundations
Name [1] 316934 0
Greenlane Research and Educational Fund
Country [1] 316934 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Country
New Zealand
Secondary sponsor category [1] 319176 0
None
Name [1] 319176 0
Address [1] 319176 0
Country [1] 319176 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315684 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315684 0
Ethics committee country [1] 315684 0
New Zealand
Date submitted for ethics approval [1] 315684 0
22/08/2024
Approval date [1] 315684 0
Ethics approval number [1] 315684 0

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

Contacts
Principal investigator
Name 135502 0
Dr Jocelyne Benatar
Address 135502 0
Cardiology Dept, Auckland City Hospital Park rd,, Grafton, Auckland, New Zealand 1030
Country 135502 0
New Zealand
Phone 135502 0
+64 21893886
Fax 135502 0
Email 135502 0
Jbenatar@adhb.govt.nz
Contact person for public queries
Name 135503 0
Jocelyne Benatar
Address 135503 0
Cardiology Dept, Auckland City Hospital Park rd,, Grafton, Auckland, New Zealand 1030
Country 135503 0
New Zealand
Phone 135503 0
+64 21893886
Fax 135503 0
Email 135503 0
Jbenatar@adhb.govt.nz
Contact person for scientific queries
Name 135504 0
Jocelyne Benatar
Address 135504 0
Cardiology Dept, Auckland City Hospital Park rd,, Grafton, Auckland, New Zealand 1030
Country 135504 0
New Zealand
Phone 135504 0
+64 21893886
Fax 135504 0
Email 135504 0
Jbenatar@adhb.govt.nz

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.