ClinicalTrials.gg
Enrolling by invitationNCT06211413SENTINELUpdated Oct 5, 2026

Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors

An observational study in Chronic Lymphocytic Leukemia, Atrial Fibrillation and Hypertension, sponsored by Abramson Cancer Center at Penn Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Chronic Lymphocytic Leukemia
  • Atrial Fibrillation
  • Hypertension
  • Cardiotoxicity

Keywords

  • Acalabrutinib
  • Zanabrutinib
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's planned enrollment of 50 is below the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥22
  • Initiation of BTK inhibitor (acalabrutinib or zanubrutinib) with or without other concurrent systemic therapy as front line or 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 and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion criteria

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
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. Incidence of hypertension

    New onset or worsening hypertension recorded on home blood pressure monitoring

    Time frame: 6 months

Secondary outcomes

  1. Incidence of atrial or ventricular arrhythmias

    Any episode of atrial or ventricular arrhythmias identified via wearable device monitoring

    Time frame: 6 months

  2. Incident episodes of major cardiovascular events

    Incident episode of stroke/TIA, other thromboembolic events, heart failure, ischemic hear events

    Time frame: 6 months

  3. Bruton's Tyrosine Kinase inhibitor discontinuation

    determination of the rate of Bruton's Tyrosine Kinase inhibitor discontinuation after development of arrhythmia

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Jun 2027, 40 months after the start.

Of 70 non-industry observational studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 30. This study's planned 40 months is below that.

Counting every sponsor, half of 104 studies reached it within 60 months; a quarter within 32 and three quarters within 176.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: primary completion Aug 2026 → Jun 2027 and completion Aug 2026 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2024
First posted
Jan 18, 2024
StartActual
Feb 7, 2024
Primary completionEst.
Jun 2027was Aug 2026
CompletionEst.
Jun 2027was Aug 2026
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 2026→Jun 2027
Oct 5, 2026
Study completion
Aug 2026→Jun 2027
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion Aug 2026→Jun 2027
    Study completion Aug 2026→Jun 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06211413
Responsible party
Sponsor
First posted
Jan 18, 2024
Start date
Feb 7, 2024
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Michael Fradley, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion