the purpose of this study is to determine whether larger dose of aldosterone antagonist Spironolactone combining with lower dose of ACE inhibitor is more effective in reverse left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: spironolactone	Phase III

Further Study Details: 

Primary Outcomes: proportion of patients whose dilated ventricle reversed to normal (we defined left ventricular end diastolic dimension [LVEDD] <55 mm in male or <50 mm in female and cardiothoracic ratio <50% is normal.)
Secondary Outcomes: Left ventricular ejection fraction (LVEF); New York Heart Association (NYHA) functional class; Six-minute walking distance; Cardiogenic death; Cardiac thoracic ratio
Expected Total Enrollment:  200

In our recent daily clinical practice, we found that the larger dose of aldosterone antagonist spironolactone combining with lower dose ACE inhibitor and highest tolerable dose of beta blockers could reverse left ventricular remodeling more effectively than smaller dose of spironolactone. The ventricular remodeling could get back to normal, especially in patients with none-ischaemic cardiomyopathy. We hypothesize that long term use of larger dose of aldosterone antagonist spironolactone could reverse left ventricular remodeling by stimulating new myocytes formation. Thus, we design 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, we routinely use larger dose of diuretic in combination with lower dose of ACE inhibitor to offset the potassium-sparing effects of spironolactone and follow the patients closely.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• New York Heart Associating(NYHA) Functional class Ⅲ,Ⅳ
• Left Ventricular Ejection Fraction (LVEF) <35%
• Nonischemic cardiomyopathy
• Preserved renal function: Cr ≤2.5 mg/dL in male , Cr ≤2.0mg/dL in female

Exclusion Criteria:

• Hyperkalemia (≥5.0mEg/L)
• Left ventricular systolic dysfunction with pericardial diseases, congenital heart diseases, pulmonary heart diseases, heart valvular diseases, acute coronary syndrome and short expected life.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125437

Chao Liu, M.D.      86 311 85917031    lcwv@sohu.com

China, Hebei
      The First Hospital of Hebei Medical University, Shijiazhuang,  Hebei,  050031,  China

Study chairs or principal investigators

Kunshen Liu, M.D.,  Principal Investigator,  The First Hospital of Hebei Medical University   

Study ID Numbers:  05276101D-84
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125437
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02