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Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

V

Vilnius University

Status and phase

Unknown
Phase 3

Conditions

Patients With Cancer

Treatments

Drug: Ivabradine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.

Full description

Cancer treatment with anthracyclines may cause heart damage and can lead to heart failure. There are drugs which may protect against cardiotoxic effects of anthracyclines (renin-angiotensin inhibitors and beta blockers), but they are not tolerated due to hypotension. Ivabradine is heart rate lowering drug without effect on blood pressure which was approved for treatment of angina pectoris and heart failure. The aim of this study is to investigate protective effects of ivabradine in cancer patients undergoing anthracycline-based chemotherapy.

Ivabradine selectively inhibits If currents in the sinus node and prolongs the duration of spontaneous depolarization. That controls the heart's contractions and regulates the heart rate. Additionally, ivabradine might preserve myocardial function and contractility without effect on blood pressure. Ivabradine was approved for symptomatic treatment of chronic stable angina pectoris and chronic heart failure.

The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.

Enrollment

128 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • cancer patients undergoing anthracyclines based chemotherapy;
  • heart rate (HR) > 70 times per minute;
  • Written informed consent.

Exclusion criteria

  • Contraindications for ivabradine administration;
  • HR<70 times per minute;
  • Incapability to complete informed consent;
  • Severe valve disease;
  • Left ventricular ejection fraction (LVEF)≤ 30 %;
  • Other severe conditions;
  • Poor echogenicity.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

128 participants in 2 patient groups

Ivabradine
Active Comparator group
Description:
Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session
Treatment:
Drug: Ivabradine
Usual care
No Intervention group
Description:
Patient will receive usual care

Trial contacts and locations

1

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Central trial contact

Sigita Aidietiene, MD, PhD; Egle Ciburiene, MD

Data sourced from clinicaltrials.gov

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