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Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study

Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study

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Phase N/A

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Overview

This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.

Description

PRIMARY OBJECTIVES:

I. To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.

II. To identify the hemodynamic changes associated with new and/or worsening HTN in patients with B-cell malignancies on BTKi by impedance cardiography (ICG) and thereby to define the optimal anti-hypertensive strategies.

III. To compare 1-year MACE rates between patients with B cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies with patients who do not develop HTN on BTKis.

OUTLINE: This is an observational study.

Patients attend hypertension clinic visits, undergo blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood sample collection and have medical records reviewed throughout study.

Eligibility

Inclusion Criteria:

  • Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL) to begin Bruton tyrosine kinase inhibitors (BTKi) treatment (either as a single agent or on combination with others), who are willing to return to Mayo Clinic for ongoing follow-up

Exclusion Criteria:

  • Patients with known central nervous system (CNS) involvement of their B-cell malignancy

Study details
    Chronic Lymphocytic Leukemia
    Hematopoietic and Lymphoid System Neoplasm
    Mantle Cell Lymphoma
    Marginal Zone Lymphoma
    Waldenstrom Macroglobulinemia

NCT06151730

Mayo Clinic

28 January 2024

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