Hypertension
Conditions
Interventions
Aliskiren added on the basal treatment
Non-RAS antihyperetensive drugs added on the basal traetment
Sponsors
The University of Tokyo, department of cardiovascular medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: History of MI more than 6 months prior to the registration, which was treated with standard of care and he/she has been clinically stable, including na&iuml;ve or standard-dose antihypertensives of RAS blockade (ACE inhibitor or ARB), CCB, diuretics, and/or beta-blocker Diagnosed with hypertension, ( home BP >125/75 mmHg or clinic BP >130/80mmHg) Not treated with Aliskiren during 1 month prior to the registration Treated with standard dose of RAS blockade, that were not modified during 1 month prior to the registration and not scheduled to be modified during the study Age=20 or >20, and <80 years old Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial Perfusion Reserve (MPR) and Ccoronary Flow Reserve (CFR) by magnetic resonance imaging (MRI) after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasao Takahashi, Yasunobu Hirata
University of Tokyo Department of Cardiovascular medicine, Graduate School of Medeicine and Faculty of Medicine
Outcome results
None listed