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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
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To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational 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
Non-interventional study
|
Outcome Measures
Primary Outcome Measures
- Incidence of major adverse cardiovascular events (MACE) [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 Outcome Measures
- Incidence of new and/or worsening hypertension (HTN) [Up to 12 months]
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).
- Hemodynamic changes associated with new and/or worsening HTN [Up to 12 months]
Impedance cardiography (ICG) changes from before to after BTKi initiation and anti-HTN therapy implication will be recorded to assess hemodynamic changes.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Joerg Herrmann, M.D., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-007083
- NCI-2023-09519
- 23-007083