A 36 week, multicenter, randomized, double-blind, placebo- controlled, parallel-group, pilot study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-AMI patients when added to optimized standard therapy
- Conditions
- Hypertension
- Registration Number
- EUCTR2006-001704-37-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. Male or female patients 18 years and older.
2. Patients within 7-42 days of an acute myocardial infarction associated with left
ventricular systolic dysfunction prior to Visit 1 (see below). A qualifying myocardial
infarction will require each of the following:
• Typical clinical presentation consistent with myocardial infarction (i.e., chest pain,
shortness of breath)
• Elevation of cardiac markers (any of the following will fulfill the requirement for
an increase in cardiac markers):
• Both total CK and CK-MB are above the upper limit of normal (ULN) and either
total CK or CK-MB are at least twice the upper limit of normal (2xULN)
• CK-MB is elevated to at least twice the upper limit of normal (2xULN) when
total CK is not available, and is confirmed by an accompanying Troponin T or I
level at least three times the upper limit of normal (3xULN)
• Total CK is elevated to at least twice the upper limit of normal (2xULN) when
CK-MB is not available, or to above the ULN if confirmed by an accompanying
Troponin T or I level at least three times the upper limit of normal (3xULN)
• Troponin T or I level is at least five times the upper limit of normal (5xULN) and
neither total CK nor CK-MB are available.
• Typical ECG changes, including evolving ST-segment or T-wave changes in two
or more contiguous ECG leads, the development of new pathological Q/QS
waves in two or more contiguous ECG leads, or the development of new left
bundle branch block.
3. 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. Systolic dysfunction will be defined by at least
one of the following criteria:
• Echocardiography: left ventricular ejection fraction (LVEF) = 40%
• Radionuclide ventriculography: LVEF = 40%
• Ventricular contrast angiography: LVEF = 35%.
4. 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
5. An evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or
Angiotensin Receptor Blocker (ARB) but not both.
6. Patients who are eligible, able to participate in the study, and who consent to do
so after the purpose and nature of the investigation has been clearly explained to
them (written informed consent).
7. Qualifying Echocardiogram:
• Patients who fulfill the screening inclusion and exclusion criteria will have a
qualifying echocardiogram performed and transmitted to the Echo Core
Laboratory. To be eligible for randomization, patients must fulfill the following
criteria by the core laboratory:
• Acceptable image quality
• Confirmed LVEF = 45%
• Qualifying Myocardial Infarct Percentage = 20% (akinetic or dyskinetic segment
length as percent of total cavity perimeter).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
For full list, please see protocol.
1. Patients requiring both ACEI and ARB combination therapy at V1 or any time
during the study.
2. Hypertrophic cardiomyopathies due to etiologies other than hypertension (i.e.,
idiopathic or valvular).
3. Severe refractory hypertension defined as MSSBP = 180 mmHg and/or MSDBP =
110 mmHg) at Visit 2.
4. Hemodynamically significant stenotic or obstructive valvular, subvalvular or
supravalvular lesions.
5. Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or
infective cardiomyopathy (e.g., Chagas’ disease).
6. Cardiogenic shock or systolic BP < 100 mmHg within the 24 hours prior to Visit 2.
7. Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD
formula at Visit 1.
8. Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1.
9. Serum potassium = 5.1 mEq/L, or dehydration at Study Visit 1.
10. Significant valvular cardiovascular disease expected to lead to cardiac surgery
during the course of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method