Intensive Medical Treatment after Heart Attack

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)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000802000

Acronym

INTENSIVE AMI-HF

Enrollment

200

Registered

2010-09-27

Start date

2010-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

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

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

Outcome results