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Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Primary Purpose

Patients With Cancer

Status
Unknown status
Phase
Phase 3
Locations
Lithuania
Study Type
Interventional
Intervention
Ivabradine
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Cancer focused on measuring anthracycline chemotherapy, cardiotoxicity, heart failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vilnius University Hospital Santaros klinikosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ivabradine

Usual care

Arm Description

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

Patient will receive usual care

Outcomes

Primary Outcome Measures

Change in left venticular dysfunction by global longitudinal strain (GLS).
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
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.
Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%.

Full Information

First Posted
July 22, 2019
Last Updated
December 16, 2019
Sponsor
Vilnius University
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1. Study Identification

Unique Protocol Identification Number
NCT04030546
Brief Title
Ivabradine to Prevent Anthracycline-induced Cardiotoxicity
Official Title
Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Prospective Randomized Open Label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Cancer
Keywords
anthracycline chemotherapy, cardiotoxicity, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Active Comparator
Arm Description
Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patient will receive usual care
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine capsule
Primary Outcome Measure Information:
Title
Change in left venticular dysfunction by global longitudinal strain (GLS).
Description
Change in global longitudinal strain (GLS) at least by 3%.
Time Frame
1, 3 and 6 months
Secondary Outcome Measure Information:
Title
Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP
Description
Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP.
Time Frame
1, 3 and 6 months
Title
Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography.
Description
Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%.
Time Frame
1, 3 and 6 months
Other Pre-specified Outcome Measures:
Title
Incidence of symptomatic heart failure.
Description
Incidence of symptomatic heart failure.
Time Frame
1, 3 and 6 months
Title
Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.
Description
Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigita Aidietiene, MD, PhD
Phone
37052365214
Email
sigita.aidietiene@santa.lt
First Name & Middle Initial & Last Name or Official Title & Degree
Egle Ciburiene, MD
Phone
37052365214
Email
egle.ciburiene@santa.lt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigita Aidietiene, MD, PhD
Organizational Affiliation
Vilnius University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University Hospital Santaros klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egle Ciburiene, MD
Email
egle.ciburiene@santa.lt
First Name & Middle Initial & Last Name & Degree
Sigita Aidietiene, MD, PhD
Email
sigita.aidietiene@santa.lt
First Name & Middle Initial & Last Name & Degree
Sigita Aidietiene, MD, PHD
First Name & Middle Initial & Last Name & Degree
Egle Ciburiene, MD
First Name & Middle Initial & Last Name & Degree
Jelena Celutkiene, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

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