NCT05521178

Cardiotoxicities in Patients Receiving BTKi

A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.

Detailed description

This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period: * Blood sample collection * Electrocardiogram (ECG) * Echocardiogram * Cardiac magnetic resonance imaging (MRI) * Mobile cardiac telemetry * Blood pressure measurement

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electrocardiogram	ECG to monitor electrical activities of the heart on each visit
DIAGNOSTIC_TEST	Echocardiogram	Echocardiogram at baseline and 6 months
DIAGNOSTIC_TEST	Cardiac magnetic resonance imaging	Cardiac MRI at baseline and 6 months
DEVICE	Mobile cardiac telemetry	Mobile cardiac telemetry at baseline and 6 months
DIAGNOSTIC_TEST	Blood pressure monitoring	Home blood pressure monitoring three times per week
DIAGNOSTIC_TEST	Blood draw	Blood draw at baseline, 3 and 6 months

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2022-08-30
• Last updated: 2024-10-15