Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)

University of Sao Paulo

Status and phase: Not yet enrolling; Phase 4

Conditions: Cardiotoxicity; Chemotherapy Effect; Neoplasms; Heart Failure

Treatments: Drug: Placebo; Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT06005259

SPIROTOX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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264 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Participants will be administered 25 mg of spironolactone daily for 12 months, beginning 5 to 15 days prior to chemotherapy.

Treatment:

Drug: Spironolactone

Control

Placebo Comparator group

Description:

Participants will be given placebo daily for 12 months, beginning 5 to 15 days prior to chemotherapy.

Treatment:

Drug: Placebo