Text Size

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
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

Resource links provided by NLM:

U.S. FDA Resources

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. Hebei Medical University First Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125437     History of Changes
Other Study ID Numbers: 05276101D-84
Study First Received: July 29, 2005
Last Updated: July 13, 2009
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013