ClinicalTrials.gov record 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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study follows people with B-cell malignancies who begin treatment with Bruton tyrosine kinase inhibitors (BTKi) to track new or worsening high blood pressure. Participants attend hypertension clinic visits and may have blood pressure monitoring, electrocardiograms (ECGs), impedance cardiography (ICG), and blood and urine samples collected. The study will compare one-year major adverse cardiovascular event (MACE) rates in those who develop HTN and receive anti-HTN strategies versus those who do not develop HTN.
What it is studying. The study aims to define how often new or worsening hypertension occurs on BTKi, identify associated hemodynamic changes using impedance cardiography to guide anti-hypertensive strategies, and compare 1-year MACE rates between people who develop HTN and those who do not.
What the researchers hope to learn. To prospectively define the incidence of new and/or worsening hypertension in patients with B-cell malignancies on BTKi; to identify hemodynamic changes associated with new and/or worsening hypertension by impedance cardiography to inform optimal anti-hypertensive strategies; and to compare 1-year major adverse cardiovascular event (MACE) rates between patients with new or worsening hypertension on optimal anti-HTN strategies and patients who do not develop hypertension on BTKi.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Non-Interventional Study
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants attend hypertension clinic visits and have their medical records reviewed while on BTKi treatment. They may undergo optional blood pressure monitoring, electrocardiograms (ECGs), and impedance cardiography (ICG) testing. Participants will give blood and urine samples for the study. Researchers will track blood pressure changes and cardiovascular events with follow-up for up to 12 months.
How the study is structured. This is a prospective observational cohort study. Participants attend hypertension clinic visits and undergo optional blood pressure monitoring, ECGs, impedance cardiography testing, and blood and urine sample collection, while researchers review medical records. Outcomes, including incidence of HTN and one-year MACE rates, are tracked over up to 12 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Jan 5, 2024
- Primary completion
- Jun 30, 2026 (estimated)
- Study completion
- Jun 30, 2026 (estimated)
- Target enrollment
- 100 participants (estimated)
- Last updated on registry
- Feb 27, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Mayo Clinic
- Principal investigator
- Joerg Herrmann, MD, Principal Investigator
Mayo Clinic
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Clinical Trials Referral Office 📞 855-776-0015 ✉ mayocliniccancerstudies@mayo.edu
Participating sites (1)
- Mayo Clinic in RochesterRecruiting
Rochester, Minnesota, 55905 · United States
- Clinical Trials Referral Office · 855-776-0015 · mayocliniccancerstudies@mayo.edu
- Joerg Herrmann, MD
Terms used on this page · explanations by MedicalUpdates.ai
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials