Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Phase 4

• Conditions: Hypertensive Left Ventricular Hypertrophy
• Interventions: Drug: Aliskiren; Drug: Eplerenone

• Registration Number: NCT01893788
• Lead Sponsor: Nagoya University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-30
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-22
• Primary Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren	Aliskiren	Aliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers.
Eplerenone	Eplerenone	Eplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers

Primary Outcome Measures

Name	Time	Method
reduction of left ventricular hypertrophy measured by magnetic resonance imaging	12 month	To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events	12 month	total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG

Trial Locations

Locations (1)

Department of Cardiology, Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Aichi, Japan