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PREAMI: Perindopril and Remodelling in Elderly with Acute Myocardial Infarction: study rationale and design
Insights
This study investigates Perindopril
Area of Science:
- Cardiology
- Pharmacology
Background:
- Angiotensin-converting enzyme (ACE) inhibitors are known to reduce mortality and improve outcomes in heart failure (HF) and acute myocardial infarction (AMI).
- Limited data exist on ACE inhibitor efficacy in elderly patients post-AMI, especially those with preserved left ventricular (LV) function.
- Elderly post-MI patients with preserved LV function face significant medium- to long-term mortality and HF incidence.
Purpose of the Study:
- To evaluate the effects of Perindopril on combined outcomes of death, HF hospitalization, and LV remodeling in elderly patients (> or =65 years) post-AMI.
- To assess secondary outcomes including individual components of the primary endpoint, drug safety, and ventricular remodeling/adaptation.
- To address the knowledge gap regarding ACE inhibitor use in elderly post-MI patients with preserved LV function.
Main Methods:
- A double-blind, randomized trial involving 1100 elderly patients (aged > or =65 years) with AMI and preserved or moderately depressed LV function (ejection fraction > or =40%).
- Participants were randomly assigned to receive either 8 mg of Perindopril or a placebo daily for 12 months.
- Assessments included clinical evaluations, quantitative 2-D echocardiography for ventricular parameters, and ambulatory electrocardiographic monitoring for heart rate variability and arrhythmias.
Main Results:
- Data and conclusions were anticipated by the year 2002.
- The study aimed to provide definitive results on Perindopril's efficacy in this specific patient population.
Conclusions:
- The study was designed to determine if Perindopril offers benefits in reducing mortality, HF hospitalizations, and LV remodeling in elderly AMI survivors with preserved LV function.
- Findings were expected to inform clinical practice guidelines for managing this demographic.
- The research aimed to clarify the role of ACE inhibitors in a previously understudied patient group.
Abstract:
Angiotensin-converting enzyme (ACE) inhibitors reduce mortality, the development of remodeling, left ventricular (LV) dysfunction, and ischemic events, both when administered alone as long-term treatment in patients with impaired LV function and/or heart failure (HF) and as short-term treatment, early after acute myocardial infarction (AMI) and/or HF. The few data available on the use of ACE inhibitors in the elderly after AMI are conflicting. Nothing is known about the effects of ACE inhibitors in elderly postinfarction patients with preserved LV function: these patients have a remarkable medium- to long-term mortality and HF incidence after infarction. The aim of this study is to evaluate, in patients with AMI aged > or =65 years, the effects of Perindopril on the combined outcome of death, hospitalization for HF, and heart remodeling, considered to be a > or =8% increase in LV end-diastolic volume (LVEDV). Secondary objectives include the same factors listed in the primary end points but considered separately. In addition, safety of the drug, ventricular remodeling, and adaptation are being evaluated. A total of 1100 patients with AMI (first episode or reinfarction), aged > or =65 years, and preserved or only moderately depressed LV (LV ejection fraction > or =40%), are to be enrolled and randomly assigned to treatment (8 mg for 12 months of Perindopril or placebo, in double-blind conditions). Clinical assessment is performed at fixed times, and periodic evaluations of (1) ventricular shape, dimensions, and function by quantitative 2-D echocardiography, and (2) heart rate variability and arrhythmias by ambulatory electrocardiographic monitoring are anticipated. The results and conclusions will be available by 2002 year.