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

Not Applicable

Terminated

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00125437
• Lead Sponsor: Hebei Medical University

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.

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 Timeline

• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study First Posted: 2005-08-01
• Study Start: 2005-09
• Status Verified: 2008-12
• Last Update Submitted: 2009-07-13
• Last Update Posted: 2009-07-15
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Left ventricular ejection fraction (LVEF)
New York Heart Association (NYHA) functional class
Six-minute walking distance
Cardiogenic death
Cardiac thoracic ratio

Trial Locations

Locations (1)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China