Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 3:07 AM
Study NCT ID:
NCT06005259
Status:
UNKNOWN
Last Update Posted:
2023-08-22
First Post:
2023-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity: a Randomized Clinical Trial (SPIROTOX Trial)
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIROTOX
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 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.
• 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: