Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors

Hypertension Clinical Trial

— SENTINEL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06211413
• Other study ID #: UPCC 43421
• Status: Enrolling by invitation
• Start date: February 7, 2024
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 an important area of investigation in the general population and is clearly an area of substantial need in the setting of BTK inhibitor use. Leveraging technology (including wearable and digital devices) to evaluate for the development of arrhythmias is an area of increasing focus in the field of cardiology and has led to various partnerships with technology companies including Apple, Google and Amazon. Several devices have shown promise in their ability to detect subclinical arrhythmias including patch and implantable recording devices, Smartwatches and digital sensors. Given the unmet need to better quantitate hypertension and arrhythmia burden in patients treated with BTK inhibitors, the investigators propose a study in which a SmartWatch, as well as at home blood pressure monitoring is used to monitor for the development of arrhythmias in either acalabrutinib- or zanubrutinib-treated CLL patients to better determine incidence and prevalence in a real world population. Based on these data, the investigators will be able to provide optimal treatment to patients while also ensuring accurate representation of hypertension and arrhythmia toxicity data which may translate into reductions in long term cardiovascular morbidity and mortality.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiotoxicity
• Chronic Lymphocytic Leukemia
• Hypertension
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypertension	New onset or worsening hypertension recorded on home blood pressure monitoring	6 months
Secondary	Incidence of atrial or ventricular arrhythmias	Any episode of atrial or ventricular arrhythmias identified via wearable device monitoring	6 months
Secondary	Incident episodes of major cardiovascular events	Incident episode of stroke/TIA, other thromboembolic events, heart failure, ischemic hear events	6 months
Secondary	Bruton's Tyrosine Kinase inhibitor discontinuation	determination of the rate of Bruton's Tyrosine Kinase inhibitor discontinuation after development of arrhythmia	6 months