Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors

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.

• 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.

Primary outcomes

• Adherence to home BP monitoring using connected BP devices over 6 months, defined as at least 144 valid measurements (≥80% of expected measurements). [Month 6]: 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)

Secondary outcomes

• - Patient satisfaction, assessed using the System Usability Scale . [Month 6]: 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.
• Detection of hypertension, based on transmitted BP values and in-clinic measurements [Throughout 6-month follow-up]: The detection of hypertension will be assessed by collecting blood pressure readings using connected blood pressure monitors and during follow-up visits
• Management of detected hypertension, including number of cardio-oncology consultations, initiation or modification of antihypertensive treatment, and adjustment of BTKi therapy [Throughout 6-month follow-up]: 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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* Known cognitive impairment
* No internet access
* Individuals under guardianship, curatorship, or legal protection

• Vanessa BEAU, Principal investigator, Centre Hospitalier Côte Basque