Status:
ENROLLING_BY_INVITATION
Hypertension and Arrhythmias in CLL Patients Treated with BTK Inhibitors
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Chronic Lymphocytic Leukemia
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Brief Summary
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 observ...
Detailed Description
Given the significant morbidity and mortality associated with hypertension and AF including stroke, systemic thromboembolism and heart failure, monitoring asymptomatic patients who are at high risk is...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06211413
Start Date
February 7 2024
End Date
August 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104