Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Sponsor

Vilnius University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04030546

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patients With Cancer	Drug: Ivabradine	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Ivabradine

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

Drug: Ivabradine

Ivabradine capsule

No Intervention: Usual care

Patient will receive usual care

Outcome Measures

Primary Outcome Measures

Change in left venticular dysfunction by global longitudinal strain (GLS). [1, 3 and 6 months]
Change in global longitudinal strain (GLS) at least by 3%.

Secondary Outcome Measures

Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP [1, 3 and 6 months]
Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP.
Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography. [1, 3 and 6 months]
Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%.

Other Outcome Measures

Incidence of symptomatic heart failure. [1, 3 and 6 months]
Incidence of symptomatic heart failure.
Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. [1, 3 and 6 months]
Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vilnius University Hospital Santaros klinikos	Vilnius		Lithuania	08661

Sponsors and Collaborators

Vilnius University

Investigators

Principal Investigator: Sigita Aidietiene, MD, PhD, Vilnius University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sigita Aidietiene, Assoc. Prof., Vilnius University

ClinicalTrials.gov Identifier:

NCT04030546

Other Study ID Numbers:

First Posted:

Jul 24, 2019

Last Update Posted:

Dec 18, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sigita Aidietiene, Assoc. Prof., Vilnius University

anthracycline chemotherapy

cardiotoxicity

heart failure

Additional relevant MeSH terms:

Cardiotoxicity

Study Results

No Results Posted as of Dec 18, 2019