Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

NCT ID: NCT01893788

Last Updated: 2013-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aliskiren

Aliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers.

Group Type: ACTIVE_COMPARATOR

Aliskiren

Intervention Type: DRUG

Aliskiren: 150 to 300 mg daily for 48 weeks

Eplerenone

Eplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers

Group Type: ACTIVE_COMPARATOR

Eplerenone

Intervention Type: DRUG

50 to 100 mg daily for 48 weeks

Interventions

Aliskiren

Aliskiren: 150 to 300 mg daily for 48 weeks

Intervention Type: DRUG

Eplerenone

50 to 100 mg daily for 48 weeks

Intervention Type: DRUG

Other Intervention Names

Rasilez; Selara

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nagoya University

OTHER

Sponsor Role: lead

Responsible Party

TOYOAKI MUROHARA

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Toyoaki Murohara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Nagoya University Graduate School of Medicine

Locations

Department of Cardiology, Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Takanori Nagahiro, MD

Role: primary

t-nagahiro@med.nagoya-u.ac.jp

81-52-744-2149

Toyoaki Murohara, MD, PhD

Role: backup

murohara@med.nagoya-u.ac.jp

81-52-744-2149

Other Identifiers

Nagoya University

Identifier Type: -

Identifier Source: org_study_id