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

Sponsor

Hebei Medical University (Other)

Overall Status

Terminated

CT.gov ID

NCT00125437

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Drug: spironolactone	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Anticipated Study Completion Date :

Sep 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.