Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Patients With Cancer Clinical Trial

Official title:

Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Prospective Randomized Open Label Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030546
• Other study ID #: ICO
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Vilnius University
• Contact: Sigita Aidietiene, MD, PhD
• Phone: 37052365214
• Email: sigita.aidietiene[@]santa.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiotoxicity
• Patients With Cancer

Intervention

Drug:
• Ivabradine
Ivabradine capsule

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros klinikos	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of symptomatic heart failure.	Incidence of symptomatic heart failure.	1, 3 and 6 months
Other	Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.	Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.	1, 3 and 6 months
Primary	Change in left venticular dysfunction by global longitudinal strain (GLS).	Change in global longitudinal strain (GLS) at least by 3%.	1, 3 and 6 months
Secondary	Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP	Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP.	1, 3 and 6 months
Secondary	Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography.	Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by = 10%.	1, 3 and 6 months