About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known cognitive impairment
No internet access
Individuals under guardianship, curatorship, or legal protection
Trial design
Single group
Treatments tested in this trial
Connected home blood pressure monitoring with daily IPA supervision.
DeviceUse 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.
Treatment groups
Trial outcomes
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).
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 .
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
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
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
Locations
Sponsors and contacts
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