Spironolactone Against Anthracycline-induced Cardiomyopathy

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT02053974

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anthracycline Induced Cardiotoxicity	Drug: Spironolactone Other: Placebo	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spironolactone patients who randomized to spironolactone administered arm	Drug: Spironolactone Spironolactone Other Names: 25 mg spironolactone orally
Placebo Comparator: Placebo Patients who randomized to placebo administered arm	Other: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: Spironolactone

patients who randomized to spironolactone administered arm

Drug: Spironolactone

Spironolactone

Other Names:

25 mg spironolactone orally

Placebo Comparator: Placebo

Patients who randomized to placebo administered arm

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Decrease in left ventricular ejection fraction [24 weeks on average]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts 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