Spironolactone Against Anthracycline-induced Cardiomyopathy

TC Erciyes University

Status and phase

Completed

Phase 4

Conditions

Anthracycline Induced Cardiotoxicity

Treatments

Other: Placebo

Drug: Spironolactone

Study type

Interventional

Funder types

Other

Identifiers

NCT02053974

Makpek-1

Details and patient eligibility

About

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

Full description

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.

Enrollment

90 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

LVEF >50%
first diagnosed breast cancer
female sex

Exclusion criteria

Prior breast cancer and/or prior anthracycline exposure history
LVEF <50%
Use of angiotensin converting enzyme inhibitors, angiotensin receptor blockers and beta blockers
Creatinin value >2 mg/dl
Presence of chronic kidney failure
Potassium value >5.3 mg/dl
Presence of adrenal gland diseases,
Presence of severe liver failure
Co-morbidities such as coronary heart disease, hypertension, atrial fibrillation, and valvular heart disease.
Male patients were excluded for the homogenization of the study