Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Study Overview
=================
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.

Conditions
-----------------
Hypertensive Left Ventricular Hypertrophy

Intervention / Treatment
-----------------
* Drug: Aliskiren
* Drug: Eplerenone


Participation Criteria
=================
Eligibility 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: History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months. Planned to taking percutaneous coronary intervention and coronary artery bypass graft Severe hypertension (≧ 180/110 mmHg) or secondary hypertension or malignant hypertension. History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months Severe valvular heart disease or atrial fibrillation Congenital heart disease Severe heart failure (NYHA functional class Ⅳ) Current treatment with aliskiren or eplerenone or diuretics Taking potassium preparation or potassium-sparing diuretic Estimated GFR ≦ 30ml/min/1.73m２ at screening or current treatment with hemodialysis Potassium > 5.0mEq/L at screening Diabetes mellitus with microalbuminuria or albuminuria Impairment of liver function (liver failure, liver cirrhosis) Pregnant woman or possibly pregnant woman History of malignant tumor include hematological neoplasm Current treatment with itraconazole, cyclosporin, ritonavir or nelfinavir Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren and/or eplerenone Current participation in another clinical trial Serious non-cardiovascular disease severely limiting life expectancy Contra-indication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aliskiren<br>Aliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers. | Drug: Aliskiren<br>* Aliskiren: 150 to 300 mg daily for 48 weeks<br>* Other names: Rasilez;|
| Active Comparator: Eplerenone<br>Eplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers | Drug: Eplerenone<br>* 50 to 100 mg daily for 48 weeks<br>* Other names: Selara;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, left ventricular hypertrophy, renin angiotensin system, aldosterone, aliskiren, eplerenone, P3NP