Hypertension Management and Cardiovascular Adverse Event Prevention in Patients with B-Cell Malignancies Undergoing Treatment with Bruton Tyrosine Kinase Inhibitors (HALT) - a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of major adverse cardiovascular events (MACE)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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 optional blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood and urine sample collection and have medical records reviewed throughout study.
Investigators
Joerg Herrmann, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL), planned to begin Bruton tyrosine kinase inhibitors (BTKi) treatment or who will start a new BTKi agent after a 5-day wash out period (either as a single agent or on combination with other chemotherapies), 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
Outcomes
Primary Outcomes
Incidence of major adverse cardiovascular events (MACE)
Time Frame: Up to 12 months
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.
Secondary Outcomes
- Incidence of new and/or worsening hypertension (HTN)(Up to 12 months)
- Hemodynamic changes associated with new and/or worsening HTN(Up to 12 months)