Clinical trial · Observational
Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors
A Prospective Longitudinal Cohort Study of the Incidence of Hypertension and Arrhythmias In Patients Treated With Bruton's Tyrosine Kinase Inhibitors For Chronic Lymphocytic Leukemia Using Wearable Technology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Acalabrutinib and Zanabrutinib are highly effective drugs used to treat Chronic Lymphocytic Leukemia, but they are associated with high blood pressure and abnormal heart rhythms. SENTINEL is an observational study that will use wearable technology to monitor heart rhythm and blood pressures at home to better understand how frequently patients are experiencing high blood pressure and/or abnormal heart rhythms.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of hypertension
- timeFrame
- 6 months
- description
- New onset or worsening hypertension recorded on home blood pressure monitoring
Secondary outcomes (3)
- measure
- Incidence of atrial or ventricular arrhythmias
- timeFrame
- 6 months
- description
- Any episode of atrial or ventricular arrhythmias identified via wearable device monitoring
- measure
- Incident episodes of major cardiovascular events
- timeFrame
- 6 months
- description
- Incident episode of stroke/TIA, other thromboembolic events, heart failure, ischemic hear events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥22 * Initiation of BTK inhibitor (acalabrutinib or zanubrutinib) with or without other concurrent systemic therapy as front line or relapsed/refractory therapy for chronic lymphocytic leukemia, ordered by treating oncologist per standard of care * Normal sinus rhythm at the time of consent * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). Exclusion Criteria: * Current use of a class IC or III antiarrhythmic medication * AF or other arrhythmia at the time of consent * Uncontrolled hypertension (≥140/90mmHg) at the time of consent * Inability to provide informed consent * Inability to wear a watch * Arm circumference too small (\< 9 in) or arm circumference too large (\> 14.5in.) to use the QardioArm cuff * Expected survival less than one year. * Pregnancy at time of consent * Lack of access to a personal Apple iPhone. If the patient does not have an Apple iPhone, but another member of the patient's household has an iPhone, the patient may still be enrolled as long as there is no other Apple Watch paired with the phone.
References
Publications (0)
Data not yet available