Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma ( FL), Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone B Cell Lymphoma, Waldenstrom Macroglobulinaemia
Conditions
Keywords
BTK inhibitor, Hypertension, Telemonitoring, Connected device, Blood pressure, Lymphoid malignancies, Advanced practice nursing, Cardio-oncology
Brief 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). The objective is to determine whether digital BP monitoring improves early detection and management of BTKi-induced hypertension over 6 months.
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.
Interventions
DEVICEConnected home blood pressure monitoring with daily IPA supervision.
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.
Sponsors
Centre Hospitalier de la côte Basque
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| - 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 |
Contacts
CONTACTSéverine LABARRERE
PRINCIPAL_INVESTIGATORVanessa BEAU
Centre Hospitalier Côte Basque
Outcome results
None listed