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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connected home blood pressure monitoring with daily IPA supervision | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| - 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. | Month 6 |
| Detection of hypertension, based on transmitted BP values and in-clinic measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Séverine LABARRERE | Contact | +33559443828 | slabarrere@ch-cotebasque.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa BEAU | Centre Hospitalier Côte Basque | Principal Investigator |
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The detection of hypertension will be assessed by collecting blood pressure readings using connected blood pressure monitors and during follow-up visits |
| 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 | Throughout 6-month follow-up |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D016393 | Lymphoma, B-Cell |
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