Anthracycline Induced Cardiotoxicity Clinical Trial
Official title:
Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy
This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04852965 -
Late Anthracycline Induced Cardiotoxicity- Childhood Cancer Survivors
|