Chronic Lymphocytic Leukemia (CLL)HEMO-CONNECTNCT07592481
Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors
A study testing Connected home blood pressure monitoring with daily IPA supervision. in people with Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma ( FL), run by Centre Hospitalier de la côte Basque.
Trial summary
This pilot prospective study aims to evaluate adherence to home blood pressure monitoring using connected blood pressure (BP) devices in patients with malignant B-cell hemopathies initiating covalent Bruton tyrosine kinase inhibitors (cBTKi). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma ( FL), Waldenstrom Macroglobulinaemia
- What is being tested?
- Connected home blood pressure monitoring with daily IPA supervision.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of lymphoid malignancy: chronic lymphocytic leukemia, follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, Waldenström macroglobulinemia, or mantle cell lymphoma
- Initiation of oral BTK inhibitor therapy (ibrutinib, acalabrutinib, or zanubrutinib), in treatment-naive or relapsed patients
- Affiliation with a social security system
- Signed written informed consent
Who cannot join
- Known cognitive impairment
- No internet access
- Individuals under guardianship, curatorship, or legal protection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This pilot prospective study aims to evaluate adherence to home blood pressure monitoring using connected blood pressure (BP) devices in patients with malignant B-cell hemopathies initiating covalent Bruton tyrosine kinase inhibitors (cBTKi). The objective is to determine whether digital BP monitoring improves early detection and management of BTKi-induced hypertension over 6 months.
Read the detailed description
Scientific justification:
Oral anticancer therapies, including cBTKi such as ibrutinib, acalabrutinib, and zanubrutinib, have transformed the treatment of various lymphoid malignancies. However, BTKi are associated with a high incidence of hypertension, reported in 20-70% of cases. Early and reliable detection is essential to avoid cardiovascular toxicity and prevent therapy discontinuation. In clinic blood pressure assessments are often limited by white-coat effect and lack of reproducibility, whereas home BP monitoring improves diagnostic accuracy and patient engagement. Despite this, there is no standardized BP monitoring strategy for patients with cBTKi.
Intervention/strategy description:
All participants will receive a validated connected blood pressure monitor and standardized training on appropriate measurement procedures. BP values will be automatically transmitted to a secure platform monitored daily by an Advanced Practice Nurse (IPA), who will ensure adherence, verify data quality, and coordinate clinical interventions when necessary.
Follow-up description:
At inclusion, patients will undergo an IPA consultation, a cardio-oncology consultation, and a medication reconciliation visit. Follow-up medical visits will be scheduled at 1, 4, and 6 months. Phone calls will be made by IPA at week 1, week 2, week 3, week 6, month 3, and month 5 to assess compliance, symptoms, and concomitant therapies. Daily connection to the monitoring platform will allow continuous verification of BP measurements and early detection of hypertension.
- Conditions
- Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma ( FL), Waldenstrom Macroglobulinaemia, Lymphoplasmacytic Lymphoma, Marginal Zone B Cell Lymphoma, Mantle Cell Lymphoma
- Being tested
- Connected home blood pressure monitoring with daily IPA supervision.
- Keywords
- BTK inhibitor, Hypertension, Telemonitoring, Connected device, Blood pressure, Lymphoid malignancies, Advanced practice nursing, Cardio-oncology
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected home blood pressure monitoring with daily IPA supervision.Device
Use of a validated connected blood pressure monitor with Bluetooth gateway; standardized patient training; daily monitoring of transmitted BP measurements; scheduled clinical visits and telephone follow-up by the IPA.
| Study group | Role | What they receive |
|---|---|---|
| Connected home blood pressure monitoring with daily IPA supervision | Experimental | Not described Receives: Device: Connected home blood pressure monitoring with daily IPA supervision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to home BP monitoring using connected BP devices over 6 months, defined as at least 144 valid measurements (≥80% of expected measurements).
Compile the number of self-measurements of blood pressure taken with connected blood pressure monitors in accordance with the recommendations (2024 European Society of Hypertension clinical practice guidelines for the management of arterial hypertension). A patient will be considered compliant if they have taken 80% of the expected measurements (i.e., 144 out of 180 measurements)
Measured: Month 6
Secondary outcomes (3)
- Patient satisfaction, assessed using the System Usability Scale .
Patient satisfaction will be assessed using the System Usability Scale questionnaire, that patients will complete at 6 months. The score will go from 10 to 50 points, 50 points is the best easy to use system.
Measured: Month 6
Detection of hypertension, based on transmitted BP values and in-clinic measurements
The detection of hypertension will be assessed by collecting blood pressure readings using connected blood pressure monitors and during follow-up visits
Measured: Throughout 6-month follow-up
Management of detected hypertension, including number of cardio-oncology consultations, initiation or modification of antihypertensive treatment, and adjustment of BTKi therapy
The management of detected hypertension will be assessed based on therapeutic interventions: number of cardio-oncology consultations, initiation or adjustment of antihypertensive therapy, and adjustment of IBTK therapy
Measured: Throughout 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de la côte Basque
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mme BEAU Vanessa, Centre Hospitalier de la côte Basque
- Investigators
- Vanessa BEAU, Principal investigator, Centre Hospitalier Côte Basque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592481
- Sponsor's protocol ID
- P-2025/04
- Acronym
- HEMO-CONNECT
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided