Clinical trial NCT03650205: Ivabradine to Prevent Anthracycline-induced Cardiotoxicity
Official title: Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Heart Failure
Cardiotoxicity
Chemotherapy Effect
Oncology
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs.

Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate.

Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.


Eligibility criteria: Inclusion Criteria:

* Age 18-year-old or older;
* Cancer diagnosis;
* Chemotherapy with anthracycline;
* Written informed consent

Exclusion Criteria:

* Chronic Kidney Disease (Creatinine clearance inferior to 30mL/min/1.73m2)
* Bradycardia (heart rate less than 60 beats per minute)
* Atrial fibrilation;
* Previous diagnosis of heart failure;
* Pregnancy;
* History of previous hypersensibility to the study drug;
* Participating in another study protocol.

Primary outcomes:
measure: Ventricular function
timeFrame: 365 days after randomization
Secondary outcomes:
measure: Composite endpoint of mortality or major cardiovascular outcomes
timeFrame: 365 days after randomization
measure: Left ventricular dysfunction
timeFrame: 365 days after randomization
measure: Incidence of myocardial injury
timeFrame: 90 days after randomization
measure: Incidence of myocardial injury
timeFrame: 180 days after randomization
measure: Incidence of myocardial injury
timeFrame: 365 days after randomization
measure: Diastolic dysfunction
timeFrame: 365 days after randomization
measure: Ventricular function
timeFrame: 180 days after randomization
Other outcomes:
measure: Composite endpoint of mortality or major cardiovascular outcomes
timeFrame: yearly after randomization until 5 years
measure: Left ventricular dysfunction
timeFrame: 180 days after randomization
measure: Incidence of myocardial injury
timeFrame: 90 days after randomization
measure: Incidence of myocardial injury
timeFrame: 180 days after randomization
measure: Diastolic dysfunction
timeFrame: 180 days after randomization
measure: Adverse events
timeFrame: 180 days after randomization
measure: Adverse events
timeFrame: 365 days after randomization
measure: Heart rate variability
timeFrame: 180 days after randomization
measure: Oxygen consumption (VO2)
timeFrame: 180 days after randomization
measure: Ventilatory equivalents for oxygen (VE/VO2) and for carbon dioxide (VE/VCO2)
timeFrame: 180 days after randomization
measure: Left Ventricular Dimensions
timeFrame: yearly after randomization until 5 years
measure: Left ventricular geometry and mass
timeFrame: yearly after randomization until 5 years
measure: Subgroup analyses regarding the primary outcome
timeFrame: 365 days after randomization
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
state: SP
Study officials:
References: