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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de la côte Basque

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Connected home blood pressure monitoring with daily IPA supervisionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Month 6

Secondary outcomes

1

- 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.

Time frame
Month 6
2

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

Time frame
Throughout 6-month follow-up
3

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

Time frame
Throughout 6-month follow-up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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