Overview

Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nagoya University
Treatments:
Angiotensin Receptor Antagonists
Eplerenone
Spironolactone
Criteria
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 Ⅳ)

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