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Trial registered on ANZCTR


Registration number
ACTRN12610000802000
Ethics application status
Not yet submitted
Date submitted
24/09/2010
Date registered
27/09/2010
Date last updated
27/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Medical Treatment after Heart Attack
Scientific title
Impact of Intensive Medical Treatment in Elderly Patients with Left Ventricle Ejection Fraction >40%, Elevated Left Ventricular Volumes and Abnormal Brain Natriuretic Peptide levels Post Acute Myocardial Infarction on new Heart Failure Hospitalisation (INTENSIVE AMI-HF)
Secondary ID [1] 252751 0
None
Universal Trial Number (UTN)
U1111-1117-2305
Trial acronym
INTENSIVE AMI-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 258252 0
Condition category
Condition code
Cardiovascular 258441 258441 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study will be randomised with 2 parallel treatment arms and separate control groups.
Patients 60years of age or older admitted with MI (ST Elevation Myocardial Infarction(STEMI), Non ST Elevation Myocardial Infarction(NSTEMI)), normal or mildly abnormal LVEF >40%, elevated Left Ventricle End Systolic Volume Index (LVESVI) >30ml/m2 or Left Ventricle End Diastolic Volume Index (LVEDVI)>75ml/m2 (10) and serum Brain Natriuretic Peptide (BNP) level >100ng/l measured 2 weeks after the event will be randomised to:
Group A - intensive therapy arm
Group B - usual therapy arm.
Patients in the intensive arm will receive appropriate oral treatment including combination of: a beta blocker (one item from the list see below) , an Angiotensin Converting Enzyme (ACE)inhibitor or (an Angiotensin Receptor Blocker (ARB) if contraindicated) (one item from the list see below) and an Angiotensin Antagonist (one item from the list see below). The choice of the drugs from the list will be at the discretion of the prescribing physician. The duration of treatment will be 12 months.
The dose of beta blocker will be titrated to the highest tolerated by the patient (at least 50% target dose).
Medications list and Dosing Targets (50% dose - target dose)
1. Beta Blockers
Carvedilol 12.5 -25mg twice daily (bd)
Bisoprolol 5-10mg once daily (od)
Metoprolol XL 95-190mg od
Nebivolol 5-10mg od
2. ACE inhibitors
Ramipril 5-10mg od
Perindopril 5-10mg od
Lisinopril 10-20mg od
3. ARB
Candesartan 12-24mg od
Irbesartan 150-300mg od
4. Aldosterone Antagonist
Spironolactone 25-50mg od
Eplerenone 25-50mg od
Intervention code [1] 257268 0
Treatment: Drugs
Comparator / control treatment
Usual treatment group will be a control and the use and doses of medications will be at the discretion of treating clinician (GP)
Control group
Active

Outcomes
Primary outcome [1] 259276 0
New heart failure hospitalisation
Timepoint [1] 259276 0
12 months from randomisation
Secondary outcome [1] 265698 0
Recurrent MI (admission to hospital with diagnosis of MI - 2 out of 3 criteria met including typical chest pain, electrocardiographic changes and positive cardiac markers)
Timepoint [1] 265698 0
12 months from randomisation
Secondary outcome [2] 265699 0
Cardiovascular Mortality (in hospital mortality or death from registry if occured in the community)
Timepoint [2] 265699 0
12 months from randomisation
Secondary outcome [3] 265700 0
Incidence of atrial fibrillation ( electrocardiographic confirmation during the study or during admission to hospital )
Timepoint [3] 265700 0
12 months from randomisation
Secondary outcome [4] 265701 0
Quality of Life using questionnaires
Timepoint [4] 265701 0
12 months from randomisation

Eligibility
Key inclusion criteria
Adult patients >60 years old 2 weeks post MI (STEMI, NSTEMI)
LVEF >40% and
LVESVI>30ml/m2 or LVEDVI>75ml/m2 and
BNP >100ng/l
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known heart failure
Known LVEF<40%
Previous MI (except the primary event)
Severe valvular heart disease
Severe life span limiting medical disease (cancer, Chronic Obstructive Pulmonary Disease (COPD) with FEV1<1.0 l, renal failure serum Creatinine >200mcmol/l)
Systolic Blood Pressure <100mmHg
Lack of consent

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)
Patients 60 years of age or older admitted to Princess Alexandra Hospital (PAH) with acute MI (STEMI, NSTEMI) and no identifiable exclusions criteria will be approached. If they agree to attend an initial visit (V0) they will be given information and consent forms.
Initial visit (V0)
During initial visit all patient concerns/questions regarding the study will be addressed. Consent form will be signed. An entry echocardiography (2D/3D) will be performed. A blood sample for BNP level and Urea and Electrolytes (U&Es)will also be drawn. QOL questionnaire will be completed.
Randomisation visit (V1)
Providing that they meet the study entry criteria patients will be randomly allocated to the intensive or usual medical treatment arms. The on site study coordinator will prepare sealed opaque envelopes with the allocation number (1- intensive, 2- usual therapy).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation will follow a random number of the study subject generation performed by our study coordinator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Both study and control group will include even numbers of patients treated with initial invasive strategy (Coronary Artery Bypass Grafting (CABG),Percutaneous Coronary Intervention (PCI)) or medical treatment only.
Randomisation will be controlled to ensure even distribution between the study arms of patients treated with either initial strategies
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257709 0
Self funded/Unfunded
Name [1] 257709 0
Dariusz Korczyk
Country [1] 257709 0
Australia
Primary sponsor type
Hospital
Name
PAH
Address
PAH
199 Ipswich Road
Woolloongabba
Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 256926 0
Other Collaborative groups
Name [1] 256926 0
Heart Failure Unit
Address [1] 256926 0
PAH
199 Ipswich Road
Woolloongabba
Brisbane QLD 4101
Country [1] 256926 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259744 0
Metro South Health Service District Human Research Committee
Ethics committee address [1] 259744 0
199 Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [1] 259744 0
Australia
Date submitted for ethics approval [1] 259744 0
01/10/2010
Approval date [1] 259744 0
Ethics approval number [1] 259744 0

Summary
Brief summary
Heart failure is a deadly condition with a 5 year survival rates of 35% following index admission, exceeding the rate of many cancers
Population based study in elderly patients (>65 years of age) indicates that among Heart Attack survivors over 70% patients develop heart failure by 5 years, more than 60% of which occurs in the first year. Currently there are no sufficient data to support an intensive medical treatment in patients after heart attack with normal or only mildly abnormal heart function.
We hypothesize that an optimised medical treatment in patients with initial normal or mild heart dysfunction but elevated Left Ventricle size (volumes) and serum cardiac hormone levels (BNP) as markers of heart remodelling (progressive weakening) may reduce the progression of the disease, delay the onset of heart failure and ultimately reduce the risk of death.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31687 0
Address 31687 0
Country 31687 0
Phone 31687 0
Fax 31687 0
Email 31687 0
Contact person for public queries
Name 14934 0
Dariusz Korczyk
Address 14934 0
PAH
199 Ipswich Road
Woolloongabba QLD 4101
Country 14934 0
Australia
Phone 14934 0
+61 7 32405442
Fax 14934 0
Email 14934 0
[email protected]
Contact person for scientific queries
Name 5862 0
Dariusz Korczyk
Address 5862 0
PAH
199 Ipswich Road
Woolloongabba QLD 4101
Country 5862 0
Australia
Phone 5862 0
+61 7 32405442
Fax 5862 0
Email 5862 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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