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出境医 / 临床实验 / Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 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 : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 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
Outcome Measures
Primary Outcome Measures :
  1. Change in left venticular dysfunction by global longitudinal strain (GLS). [ Time Frame: 1, 3 and 6 months ]
    Change in global longitudinal strain (GLS) at least by 3%.


Secondary Outcome Measures :
  1. Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP [ Time Frame: 1, 3 and 6 months ]
    Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP.

  2. Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography. [ Time Frame: 1, 3 and 6 months ]
    Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%.


Other Outcome Measures:
  1. Incidence of symptomatic heart failure. [ Time Frame: 1, 3 and 6 months ]
    Incidence of symptomatic heart failure.

  2. Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. [ Time Frame: 1, 3 and 6 months ]
    Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Sigita Aidietiene, MD, PhD 37052365214 sigita.aidietiene@santa.lt
Contact: Egle Ciburiene, MD 37052365214 egle.ciburiene@santa.lt

Locations
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Lithuania
Vilnius University Hospital Santaros klinikos Recruiting
Vilnius, Lithuania, 08661
Contact: Egle Ciburiene, MD       egle.ciburiene@santa.lt   
Contact: Sigita Aidietiene, MD, PhD       sigita.aidietiene@santa.lt   
Principal Investigator: Sigita Aidietiene, MD, PHD         
Sub-Investigator: Egle Ciburiene, MD         
Sub-Investigator: Jelena Celutkiene, MD, PHD         
Sponsors and Collaborators
Vilnius University
Investigators
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Principal Investigator: Sigita Aidietiene, MD, PhD Vilnius University
Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019) 		Change in left venticular dysfunction by global longitudinal strain (GLS). [ Time Frame: 1, 3 and 6 months ]
Change in global longitudinal strain (GLS) at least by 3%.
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019) 		Incidence of left venticle dysfunction by global longitudinal strain (GLS) reduction. [ Time Frame: 1, 3 and 6 months ]
Global longitudinal strain (GLS) reduction of ≥ 3%.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP [ Time Frame: 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. [ Time Frame: 1, 3 and 6 months ]
    Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2019)
  • Incidence of symptomatic heart failure. [ Time Frame: 1, 3 and 6 months ]
    Incidence of symptomatic heart failure.
  • Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. [ Time Frame: 1, 3 and 6 months ]
    Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.
Original Other Pre-specified Outcome Measures
 (submitted: July 23, 2019)
  • Incidence of symptomatic heart failure. [ Time Frame: 1, 3 and 6 months ]
    Incidence of symptomatic heart failure.
  • Changes in left ventricle and right ventricle dimensions by 2D and 3D echocardiography. [ Time Frame: 1, 3 and 6 months ]
    Changes in left ventricle and right ventricle dimensions by 2D and 3D echocardiography.
 
Descriptive Information
Brief Title  ICMJE Ivabradine to Prevent Anthracycline-induced Cardiotoxicity
Official Title  ICMJE Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Prospective Randomized Open Label Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patients With Cancer
Intervention  ICMJE Drug: Ivabradine
Ivabradine capsule
Study Arms  ICMJE
  • Active Comparator: Ivabradine
    Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session
    Intervention: Drug: Ivabradine
  • No Intervention: Usual care
    Patient will receive usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2019) 		128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sigita Aidietiene, MD, PhD 37052365214 sigita.aidietiene@santa.lt
Contact: Egle Ciburiene, MD 37052365214 egle.ciburiene@santa.lt
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04030546
Other Study ID Numbers  ICMJE ICO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sigita Aidietiene, Vilnius University
Study Sponsor  ICMJE Vilnius University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sigita Aidietiene, MD, PhD Vilnius University
PRS Account Vilnius University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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