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

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ClinicalTrials.gov Identifier: NCT01893788
Recruitment Status : Unknown
Verified July 2013 by TOYOAKI MUROHARA, Nagoya University.
Recruitment status was:  Recruiting
First Posted : July 9, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
TOYOAKI MUROHARA, 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.

Condition or disease Intervention/treatment Phase
Hypertensive Left Ventricular Hypertrophy Drug: Aliskiren Drug: Eplerenone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2013
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Selara




Primary Outcome Measures :
  1. reduction of left ventricular hypertrophy measured by magnetic resonance imaging [ Time Frame: 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 :
  1. Cardiovascular events [ Time Frame: 12 month ]
    total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG


Other Outcome Measures:
  1. Biochemical parameters [ Time Frame: 12 month ]
    BNP, PIIINP etc



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893788


Locations
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Japan
Department of Cardiology, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Aichi, Japan, 466-8550
Contact: Takanori Nagahiro, MD    81-52-744-2149    t-nagahiro@med.nagoya-u.ac.jp   
Contact: Toyoaki Murohara, MD, PhD    81-52-744-2149    murohara@med.nagoya-u.ac.jp   
Sponsors and Collaborators
Nagoya University
Investigators
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Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine

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Responsible Party: TOYOAKI MUROHARA, Professor of Medicine, Nagoya University
ClinicalTrials.gov Identifier: NCT01893788     History of Changes
Other Study ID Numbers: Nagoya University
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013
Keywords provided by TOYOAKI MUROHARA, Nagoya University:
hypertension
left ventricular hypertrophy
renin angiotensin system
aldosterone
aliskiren
eplerenone
P3NP
Additional relevant MeSH terms:
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Eplerenone
Hypertrophy, Left Ventricular
Hypertrophy
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents