Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy - Tabular View

Tracking Information

First Received Date ^ICMJE

July 29, 2005

Last Updated Date

July 13, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

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.)

Change History

Complete list of historical versions of study NCT00125437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Heart Failure, Congestive

Intervention ^ICMJE

Drug: spironolactone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

September 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00125437

Responsible Party

Study ID Numbers ^ICMJE

05276101D-84

Study Sponsor ^ICMJE

Hebei Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kunshen Liu, M.D.

The First Hospital of Hebei Medical University

Information Provided By

Hebei Medical University

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP