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

Information source: Hebei Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure, Congestive

Intervention: spironolactone (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Hebei Medical University

Official(s) and/or principal investigator(s):
Kunshen Liu, M.D., Principal Investigator, Affiliation: Hebei Medical University First Hospital

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

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

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

Starting date: September 2005
Last updated: July 13, 2009

Page last updated: August 23, 2015

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