Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

NCT04030546 | Unknown Phase 3

• 1 other identifier: ICO
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients With Cancer

Keywords

anthracycline chemotherapy; cardiotoxicity; heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP

  1, 3 and 6 months

• Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography.

  1, 3 and 6 months

Other Outcomes (2)

• Incidence of symptomatic heart failure.

  1, 3 and 6 months

• Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.

  1, 3 and 6 months

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR

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

Drug: Ivabradine

Usual care

NO INTERVENTION

Patient will receive usual care

Interventions

Ivabradine DRUG

Ivabradine capsule

Ivabradine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Hospital Santaros klinikos

Vilnius, 08661, Lithuania

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Heart Failure

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sigita Aidietiene, MD, PhD

  Vilnius University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigita Aidietiene, MD, PhD

CONTACT

37052365214; sigita.aidietiene@santa.lt

Egle Ciburiene, MD

CONTACT

37052365214; egle.ciburiene@santa.lt

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: December 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)