Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

Heart Failure, Congestive Clinical Trial

Official title:

Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00125437
• Other study ID #: 05276101D-84
• Status: Terminated
• Phase: N/A
• First received: July 29, 2005
• Last updated: July 13, 2009
• Start date: September 2005
• Est. completion date: September 2009

Study information

• Verified date: December 2008
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• New York Heart Association (NYHA) Functional class ? or ?

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• spironolactone

Locations

Country	Name	City	State
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Left ventricular ejection fraction (LVEF)
Secondary	New York Heart Association (NYHA) functional class
Secondary	Six-minute walking distance
Secondary	Cardiogenic death
Secondary	Cardiac thoracic ratio