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

Primary Purpose

Hypertensive Left Ventricular Hypertrophy

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aliskiren
Eplerenone
Sponsored by
Nagoya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Left Ventricular Hypertrophy focused on measuring hypertension, left ventricular hypertrophy, renin angiotensin system, aldosterone, aliskiren, eplerenone, P3NP

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Nagoya University Graduate School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aliskiren

Eplerenone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cardiovascular events
total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG

Full Information

First Posted
April 30, 2013
Last Updated
July 18, 2013
Sponsor
Nagoya University
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1. Study Identification

Unique Protocol Identification Number
NCT01893788
Brief Title
Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy
Acronym
EARTH
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Left Ventricular Hypertrophy
Keywords
hypertension, left ventricular hypertrophy, renin angiotensin system, aldosterone, aliskiren, eplerenone, P3NP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren
Arm Type
Active Comparator
Arm Description
Aliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers.
Arm Title
Eplerenone
Arm Type
Active Comparator
Arm Description
Eplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Rasilez
Intervention Description
Aliskiren: 150 to 300 mg daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Selara
Intervention Description
50 to 100 mg daily for 48 weeks
Primary Outcome Measure Information:
Title
reduction of left ventricular hypertrophy measured by magnetic resonance imaging
Description
To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Cardiovascular events
Description
total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG
Time Frame
12 month
Other Pre-specified Outcome Measures:
Title
Biochemical parameters
Description
BNP, PIIINP etc
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toyoaki Murohara, MD, PhD
Organizational Affiliation
Department of Cardiology, Nagoya University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Nagoya University Graduate School of Medicine
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takanori Nagahiro, MD
Phone
81-52-744-2149
Email
t-nagahiro@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Toyoaki Murohara, MD, PhD
Phone
81-52-744-2149
Email
murohara@med.nagoya-u.ac.jp

12. IPD Sharing Statement

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Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

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