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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Active Comparator | patients who randomized to spironolactone administered arm |
|
| Placebo | Placebo Comparator | Patients who randomized to placebo administered arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | Spironolactone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in left ventricular ejection fraction | 24 weeks on average |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmut Akpek, M.D. | Erciyes University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University School of Medicine | Kayseri | 38039 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25410653 | Derived | Akpek M, Ozdogru I, Sahin O, Inanc M, Dogan A, Yazici C, Berk V, Karaca H, Kalay N, Oguzhan A, Ergin A. Protective effects of spironolactone against anthracycline-induced cardiomyopathy. Eur J Heart Fail. 2015 Jan;17(1):81-9. doi: 10.1002/ejhf.196. Epub 2014 Nov 20. |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Other | Placebo |
|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |