Clinical Trial: Spironolactone Against Anthracycline-induced Cardiomyopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy

Brief Summary: This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.

Detailed Summary:

Anthracyclines are the cornerstone in the treatment of numerous hematological and solid cancers. The most common side effect of anthracycline is cardiotoxicity and this may limits its use and increases the rate of mortality and morbidity. Cardiotoxicity is cumulative, dose dependent, and irreversible. Improvements in protective mechanisms against the cardiotoxicity of anthracycline are important to prevent the discontinuance of these chemotherapeutics.

Spironolactone is an aldosterone antagonist which blocks the last step of the rennin angiotensin aldosterone system (RAAS). The RAAS is one of the most effective systems in remodeling of the myocardium in post-myocardial damage. According to the RALES study, in patients with severe heart failure, 25 mg spironolactone per day in addition to the standard therapy has positive effects, particularly on cardiac fibrosis and on remodeling, and substantially reduces the risk of both morbidity and death. In the EPHESUS study, it has been shown that, after the myocardial damage due to infarction, the administration of aldosterone antagonists had positive effects on the remodeling process, left ventricular ejection fraction and primer end-points. In the present study, we tested the hypothesis that RAAS blockage with spironolactone may reduce the cardiotoxicity of anthracycline group chemotherapeutics.

Sponsor: TC Erciyes University

Current Primary Outcome: Decrease in left ventricular ejection fraction [ Time Frame: 24 weeks on average ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: TC Erciyes University

Dates:
Date Received: January 30, 2014
Date Started: September 2011
Date Completion:
Last Updated: February 1, 2014
Last Verified: February 2014