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.)
Sponsor:
Information provided by:
Hebei Medical University
ClinicalTrials.gov Identifier:
NCT00125437
First received: July 29, 2005
Last updated: July 13, 2009
Last verified: December 2008

July 29, 2005
July 13, 2009
September 2005
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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)
proportion of patients whose dilated ventricle reversed to normal (we defined left ventricular end diastolic dimension [LVEDD] <55 mm in male or <50 mm in female and cardiothoracic ratio <50% is normal.)
Complete list of historical versions of study NCT00125437 on ClinicalTrials.gov Archive Site
  • Left ventricular ejection fraction (LVEF)
  • New York Heart Association (NYHA) functional class
  • Six-minute walking distance
  • Cardiogenic death
  • Cardiac thoracic ratio
Same as current
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Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: spironolactone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
September 2009
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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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00125437
05276101D-84
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Hebei Medical University
Not Provided
Principal Investigator: Kunshen Liu, M.D. Hebei Medical University First Hospital
Hebei Medical University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP