Trial record 14 of 37 for:    eplerenone | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Nagoya University
Sponsor:
Information provided by (Responsible Party):
TOYOAKI MUROHARA, Nagoya University
ClinicalTrials.gov Identifier:
NCT01893788
First received: April 30, 2013
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Hypertensive Left Ventricular Hypertrophy
Drug: Aliskiren
Drug: Eplerenone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nagoya University:

Primary Outcome Measures:
  • reduction of left ventricular hypertrophy measured by magnetic resonance imaging [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG


Other Outcome Measures:
  • Biochemical parameters [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    BNP, PIIINP etc


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893788

Locations
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
Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: TOYOAKI MUROHARA, Professor of Medicine, Nagoya University
ClinicalTrials.gov Identifier: NCT01893788     History of Changes
Other Study ID Numbers: Nagoya University
Study First Received: April 30, 2013
Last Updated: July 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nagoya University:
hypertension
left ventricular hypertrophy
renin angiotensin system
aldosterone
aliskiren
eplerenone
P3NP

Additional relevant MeSH terms:
Eplerenone
Hypertrophy
Hypertrophy, Left Ventricular
Cardiomegaly
Cardiovascular Diseases
Heart Diseases
Pathological Conditions, Anatomical
Angiotensin Receptor Antagonists
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015