NCT06151730

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-11-30
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States