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

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

Detailed Description
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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.

Official Title
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Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-Cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors (HALT) - A Pilot Study

Conditions
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Chronic Lymphocytic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia

Intervention / Treatment
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* Other: Non-Interventional Study


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients attend hypertension clinic visits, undergo blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood sample collection and have medical records reviewed throughout study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiovascular events (MACE) | 1-year MACE rates between patients with B-cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies will be compared with patients who do not develop HTN on BTKi. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new and/or worsening hypertension (HTN) | Incidence of new or worsening HTN over 1 year of BTKi therapy will be recorded (defined as blood pressure (BP) increase to>140 mmHg systolic or > 90 mmHg diastolic). | Up to 12 months | 
| Hemodynamic changes associated with new and/or worsening HTN | Impedance cardiography (ICG) changes from before to after BTKi initiation and anti-HTN therapy implication will be recorded to assess hemodynamic changes. | Up to 12 months |