Spironolactone Against Anthracycline-induced Cardiomyopathy

Anthracycline Induced Cardiotoxicity Clinical Trial

Official title:

Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053974
• Other study ID #: Makpek-1
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2014
• Last updated: February 1, 2014
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2014
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anthracycline Induced Cardiotoxicity
• Cardiomyopathies

Intervention

Drug:
• Spironolactone
Spironolactone

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Turkey	Erciyes University School of Medicine	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in left ventricular ejection fraction		24 weeks on average	No