Hypertensive Left Ventricular Hypertrophy Clinical Trial
— EARTH| Verified date | July 2013 |
| Source | Nagoya University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Male or female ? 20 years of age Clinical diagnosis of hypertension Patients who are able to provide written informed consent Exclusion Criteria: 1. History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months. 2. Planned to taking percutaneous coronary intervention and coronary artery bypass graft 3. Severe hypertension (? 180/110 mmHg) or secondary hypertension or malignant hypertension. 4. History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months 5. Severe valvular heart disease or atrial fibrillation 6. Congenital heart disease 7. Severe heart failure (NYHA functional class ?) 8. Current treatment with aliskiren or eplerenone or diuretics 9. Taking potassium preparation or potassium-sparing diuretic 10. Estimated GFR ? 30ml/min/1.73m2 at screening or current treatment with hemodialysis 11. Potassium > 5.0mEq/L at screening 12. Diabetes mellitus with microalbuminuria or albuminuria 13. Impairment of liver function (liver failure, liver cirrhosis) 14. Pregnant woman or possibly pregnant woman 15. History of malignant tumor include hematological neoplasm 16. Current treatment with itraconazole, cyclosporin, ritonavir or nelfinavir 17. Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren and/or eplerenone 18. Current participation in another clinical trial 19. Serious non-cardiovascular disease severely limiting life expectancy 20. Contra-indication to MRI |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Department of Cardiology, Nagoya University Graduate School of Medicine | Nagoya | Aichi |
| Lead Sponsor | Collaborator |
|---|---|
| Nagoya University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Biochemical parameters | BNP, PIIINP etc | 12 month | No |
| Primary | reduction of left ventricular hypertrophy measured by magnetic resonance imaging | To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline. | 12 month | Yes |
| Secondary | Cardiovascular events | total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG | 12 month | Yes |