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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Drug: spironolactone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: spironolactone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) |  |  | 
| New York Heart Association (NYHA) functional class |  |  | 
| Six-minute walking distance |  |  | 
| Cardiogenic death |  |  | 
| Cardiac thoracic ratio |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aldosterone antagonists, spironolactone, left ventricular remodeling