Ivabradine to Prevent Anthracycline-induced Cardiotoxicity (IPAC)

University of Sao Paulo

Status: Unknown

Conditions: Cardiotoxicity; Chemotherapy Effect; Oncology; Neoplasms; Heart Failure

Treatments: Drug: Ivabradine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03650205

42559415520020065

Details and patient eligibility

About

Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs.

Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate.

Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-year-old or older;
• Cancer diagnosis;
• Chemotherapy with anthracycline;
• Written informed consent

Exclusion criteria

• Chronic Kidney Disease (Creatinine clearance inferior to 30mL/min/1.73m2)
• Bradycardia (heart rate less than 60 beats per minute)
• Atrial fibrilation;
• Previous diagnosis of heart failure;
• Pregnancy;
• History of previous hypersensibility to the study drug;
• Participating in another study protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Ivabradine

Active Comparator group

Description:

Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until one month after the last chemotherapy session.

Treatment:

Drug: Ivabradine

Placebo

Placebo Comparator group

Description:

Patients will receive placebo just before anthracycline chemotherapy, one capsule per oral twice daily, until one month after the last chemotherapy session.

Treatment:

Drug: Placebo