Status:
UNKNOWN
Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)
Lead Sponsor:
University of Sao Paulo
Conditions:
Cardiotoxicity
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate the effect of spironolactone in the primary prevention of cardiotoxicity in cancer patients who are undergoing chemotherapy with anthracycline within 12 ...
Detailed Description
Objective: To assess the potential of spironolactone in preventing anthracycline-induced cardiotoxicity among cancer patients. Background: There's ongoing debate and a dearth of evidence regarding ...
Eligibility Criteria
Inclusion
- Patients diagnosed with cancer indicated for anthracycline chemotherapy treatment
- Age 18 and above
- Signed informed consent form
Exclusion
- Previous use of anthracycline.
- Hypersensitivity to any mineralocorticoid receptor antagonists
- Symptoms of heart failure (exertional dyspnea, orthopnea, nocturnal paroxysmal dyspnea, and pulmonary or systemic congestion)
- Left ventricular ejection fraction (LVEF) \< 45%
- Previous diagnosis of cardiomyopathy, coronary artery disease, or moderate to severe mitral or aortic disease
- Renal insufficiency defined as an estimated glomerular filtration rate \< 30 ml/min/m2
- Hyperkalemia, defined as serum potassium ≥ 5.0 mmol/L
- Chronic liver disease, defined aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values more than 3 times the upper limit of normal
- Current participation in another study
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06005259
Start Date
October 1 2023
End Date
December 1 2025
Last Update
August 22 2023
Active Locations (1)
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1
Instituto do Coração
São Paulo, Brazil, 05403-000