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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with B-cell malignancies on BTKi treatment at Mayo Clinic.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 months

Secondary outcomes

1

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).

Time frame
Up to 12 months
2

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.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

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