Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors

NCT06211413 | Enrolling By Invitation

• 1 other identifier: UPCC 43421
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Atrial Fibrillation; Hypertension; Cardiotoxicity; Chronic Lymphocytic Leukemia

Keywords

Acalabrutinib; Zanabrutinib

Outcome Measures

Primary Outcomes (1)

• Incidence of hypertension

  New onset or worsening hypertension recorded on home blood pressure monitoring

  6 months

Secondary Outcomes (3)

• Incidence of atrial or ventricular arrhythmias

  6 months

• Incident episodes of major cardiovascular events

  6 months

• Bruton's Tyrosine Kinase inhibitor discontinuation

  6 months

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Lymphocytic Leukemia initiating therapy with acalabrutinib and/or zanabrutinib will be evaluated for eligibility.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Atrial Fibrillation; Hypertension; Cardiotoxicity

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Michael Fradley, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 18, 2024
• Study Start: February 7, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)