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Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
This study has been terminated.
( Poor compliance with the therapy and lot of patients were lost to follow up. )
First Received: July 29, 2005   Last Updated: December 22, 2008   History of Changes
Sponsored by: Hebei Medical University
Information provided by: Hebei Medical University
ClinicalTrials.gov Identifier: NCT00125437
  Purpose

The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy.


Condition Intervention
Heart Failure, Congestive
Drug: spironolactone

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • Proportion of patients whose dilated ventricle reversed to normal (left ventricular end diastolic dimension [LVEDD] defined as <55 mm in males or <50 mm in females and cardiothoracic ratio <50% is normal)

Secondary Outcome Measures:
  • Left ventricular ejection fraction (LVEF)
  • New York Heart Association (NYHA) functional class
  • Six-minute walking distance
  • Cardiogenic death
  • Cardiac thoracic ratio

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: September 2009
Detailed Description:

In the investigators' recent daily clinical practice, they found that the larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor and the highest tolerable dose of beta blockers could reverse left ventricular remodeling more effectively than a smaller dose of spironolactone. The ventricular remodeling could get back to normal, especially in patients with none-ischaemic cardiomyopathy. The investigators hypothesize that long term use of a larger dose of the aldosterone antagonist spironolactone could reverse left ventricular remodeling by stimulating new myocyte formation. Thus, they designed this study to verify its efficacy and safety in reversing left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy. To avoid hyperkalemia, the investigators routinely use larger doses of diuretics in combination with a lower dose of an ACE inhibitor to offset the potassium-sparing effects of spironolactone and follow the patients closely.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New York Heart Association (NYHA) Functional class Ⅲ or Ⅳ
  • Left Ventricular Ejection Fraction (LVEF) <35%
  • Nonischemic cardiomyopathy
  • Preserved renal function: Cr ≤2.5 mg/dL in males; Cr ≤2.0mg/dL in females

Exclusion Criteria:

  • Hyperkalemia (≥5.0 mEg/L)
  • Left ventricular systolic dysfunction with pericardial diseases, congenital heart diseases, pulmonary heart diseases, heart valvular diseases, acute coronary syndrome and short life expectancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125437

Locations
China, Hebei
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University
Investigators
Principal Investigator: Kunshen Liu, M.D. The First Hospital of Hebei Medical University
  More Information

Additional Information:
No publications provided

Study ID Numbers: 05276101D-84
Study First Received: July 29, 2005
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00125437     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Hebei Medical University:
aldosterone antagonists
spironolactone
left ventricular remodeling

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Aldosterone Antagonists
Hormone Antagonists
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Hormones
Cardiomyopathies
Spironolactone

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Cardiomyopathies
Pharmacologic Actions
Spironolactone
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 06, 2009