Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
Information source: Hebei Medical University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive
Intervention: spironolactone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hebei Medical University Official(s) and/or principal investigator(s):
Kunshen Liu, M.D., Principal Investigator, Affiliation: The First Hospital of Hebei Medical University
Overall contact:
Chao Liu, M.D., Phone: 86 311 85917031, Email: lcwv@sohu.com
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.
Clinical Details
Official title: Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
Study design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Left ventricular ejection fraction (LVEF)New York Heart Association (NYHA) functional class Six-minute walking distance Cardiogenic death Cardiac thoracic ratio
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Chao Liu, M.D., Phone: 86 311 85917031, Email: lcwv@sohu.com
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China; Recruiting
Kunshen Liu, M.D., Phone: 86 311 85617033, Email: ksliud@sohu.com
Additional Information
Starting date: September 2005
Ending date: September 2009
Last updated: June 18, 2007
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