Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy (EARTH)

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.

Study Overview

• Status: Unknown
• Conditions: Hypertensive Left Ventricular Hypertrophy
• Intervention / Treatment: Drug: Aliskiren; Drug: Eplerenone

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 466-8550
      • Recruiting
      • Department of Cardiology, Nagoya University Graduate School of Medicine
      • Contact: Toyoaki Murohara, MD, PhD; Phone Number: 81-52-744-2149; Email: murohara@med.nagoya-u.ac.jp
      • Contact: Takanori Nagahiro, MD; Phone Number: 81-52-744-2149; Email: t-nagahiro@med.nagoya-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical parameters	BNP, PIIINP etc	12 month

Collaborators and Investigators

• Sponsor: Nagoya University
• Investigators: Principal Investigator: Toyoaki Murohara, MD, PhD, Department of Cardiology, Nagoya University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 22, 2013
• Last Update Submitted That Met QC Criteria: July 18, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: hypertension; aldosterone; aliskiren; eplerenone; renin angiotensin system; left ventricular hypertrophy; P3NP
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Cardiomegaly; Hypertrophy; Hypertrophy, Left Ventricular; Physiological Effects of Drugs; Antihypertensive Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Eplerenone
• Other Study ID Numbers: Nagoya University