A Single Center, Open-label, Randomized Comparative Study to Evaluate the Effect of Aliskiren on Myocardial Perfusion Reserve and Coronary Flow Reserve in Hypertensive Patients with a history of Myocardial Infarctio
- Conditions
- Hypertension
- Registration Number
- JPRN-UMIN000005511
- Lead Sponsor
- The University of Tokyo, department of cardiovascular medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
1.Intolerance, anaphylaxis, or any history of hypersensitivity to aliskiren 2.Treated with high dose of RAS blockade 3.Initiation or change-a-dose/discontinuation of statin during 3 months prior to the registration, or planned change in a dose of statin during participating to this study 4.History of coronary artery bypass graft surgery 5.With any contraindication for MRI a)Pacemaker or ICD b)Implanted inner ear device c)Artificial tooth (regarded as an aberration if provided, however, that physician decided it doesn't matter) d)patient undergoing bronchial asthma treatment e)History of artificial vessel replacement for aortic aneurysm f)History of surgical clip therapy for brain aneurysm g)eGFR<50mL/min/1.73 m2 during 1 month prior to the MRI examination h)Judged as "Imcompetent for the study" by investigators i)Intolerance, anaphylaxis, or any history of hypersensitivity to Gd-DTPA 6.Uncontrolled severe diabetes ( HbA1c>9) 7.Unstable angina or a history of acute MI or stroke during 3 months prior to the registration 8.LVEF <30% 9.Severe liver dysfunction 10.Severe kidney disease 11.Pregnant, Women of Child Bearing Potential or using effective methods of contraception as defined by local Health Authority 12.Nursing (lactating) women 13.Hyperkalemia ( plasma K >5.5mEq/l) 14.eGFR<50mL/min/1.73 m2 during 1 month prior to the registration 15.Judged as "Imcompetent for the study" by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Myocardial Perfusion Reserve (MPR) and Ccoronary Flow Reserve (CFR) by magnetic resonance imaging (MRI) after 24 weeks
- Secondary Outcome Measures
Name Time Method 1.Left ventricule mass, End-diastolic and end-systolic left ventricular volume (EDV and ESV) after 24 weeks 2.Change from baseline in systolic and diastolic blood pressure after 12 and 24 weeks 3.Biomarkers including BNP, hs-CRP, PRA and plasma aldosterone after 12 and 24 weeks