A 36 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarct patients when added to optimized standard therapy

Phase 3

Completed

• Conditions: heart attack; myocardial infarct; 10028593

• Registration Number: NL-OMON30339
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

See protocol for complete criteria (page 17);*Male and female patients 18 years and older.
*Patients within 7-42 days of an acute myocardial infarction.
*Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial infarction obtained as a clinical study at least 5 days after the qualifying MI but prior to Visit 1.
*Patients must be on stable doses of the following concomitant medications for at least 2 weeks prior to Visit 1 unless contraindicated due to intolerance:
* A Beta-blocker
* An Anti-platelet agent
* A Statin
* An evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both.

Exclusion Criteria

See protocol for complete criteria (page 18)
*Patients requiring both ACE and ARB combination therapy at Visit 1.
*Severe refractory hypertension defined as MSSBP *180 mmHg and/or MSDBP * 110 mmHg at randomization (visit 2).
*Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy
*Stroke or transchemient ischemic event (TIA) within 6 months of Study visit 1.
*Serum potassium *5.1 mEq/L, or dehydration at study visit 1
*Estimated Glomerular filtration rate < 30ml/min/1.73m2 using the MDRD formula at visit 1
*Unstable angina requiring intervention between visit 1 and visit 2.
*Any coronary artery revascularization procedure within 7 days prior to visit 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Echocardiography:<br /><br>The primary efficacy endpoint will be change in left ventricular end systolic<br /><br>volume (LVESV) from baseline to end of study. Additional echocardiographic<br /><br>measures will serve as secondary endpoints, including left ventricular<br /><br>end-diastolic volume (LVEDV) and left ventricular ejection fraction (LVEF).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cardiac MRI (in a subset of patients- not in the Netherlands):<br /><br>*RV and LV volumes, LVEF, and myocardial infarct related scarring as determined<br /><br>by contrast enhanced MRI.<br /><br><br /><br>Composite clinical endpoints:<br /><br>*a composite outcome of CV death, hospitalization for heart failure, or a<br /><br>reduction in left ventricular ejection fraction greater than 6 units (absolute<br /><br>percentage points)<br /><br>*a composite outcome of CV death, hospitalization for heart failure, recurrent<br /><br>myocardial infarction, stroke or resuscitated sudden death.</p><br>