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Spironolactone Against Anthracycline-induced Cardiomyopathy

Information source: TC Erciyes University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anthracycline Induced Cardiotoxicity

Intervention: Spironolactone (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: TC Erciyes University

Official(s) and/or principal investigator(s):
Mahmut Akpek, M.D., Principal Investigator, Affiliation: Erciyes University School of Medicine

Summary

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

Clinical Details

Official title: Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy

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

Primary outcome: Decrease in left ventricular ejection fraction

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.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Erciyes University School of Medicine, Kayseri 38039, Turkey
Additional Information

Starting date: September 2011
Last updated: February 1, 2014

Page last updated: August 23, 2015

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