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Trial Title:
Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)
NCT ID:
NCT06005259
Condition:
Cardiotoxicity
Neoplasms
Chemotherapy Effect
Heart Failure
Conditions: Official terms:
Cardiotoxicity
Spironolactone
Conditions: Keywords:
Cardiotoxicity
Anthracyclines
Spironolactone
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Spironolactone
Description:
Spironolactone 25 mg capsule
Arm group label:
Intervention
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo capsule
Arm group label:
Control
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 months. The main question it aims to answer is:
• Does spironolactone reduce the incidence of cardiotoxicity in patients undergoing
anthracycline chemotherapy?
Participants will:
- Be cancer patients over 18 years starting treatment with anthracycline;
- Be randomized to receive either spironolactone or a placebo for 1 year;
- Undergo assessments of their left ventricular ejection fraction (LVEF), global
longitudinal strain, and cardiac biomarkers over the 12-month period.
Researchers will compare the spironolactone group to the placebo group to see if
cardiotoxicity incidence differs between the two.
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 the role of mineralocorticoid
receptor antagonists, such as spironolactone, in averting anthracycline-induced
cardiotoxicity.
Study Design:
A randomized, double-blind, placebo-controlled trial conducted at a single center.
Sample Size:
264 patients.
Intervention:
Eligible participants will be randomized on a 1:1 basis to either receive spironolactone
or a placebo over a 12-month period.
Primary Outcome:
Incidence of cardiotoxicity at the 12-month mark.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients diagnosed with cancer indicated for anthracycline chemotherapy treatment
- Age 18 and above
- Signed informed consent form
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto do Coração
Address:
City:
São Paulo
Zip:
05403-000
Country:
Brazil
Start date:
October 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
University of Sao Paulo
Agency class:
Other
Source:
University of Sao Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06005259
