Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors (HEMO-CONNECT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Séverine LABARRERE
- Phone Number: +33559443828
- Email: slabarrere@ch-cotebasque.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Connected 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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).
Time Frame: 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)
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
- Patient satisfaction, assessed using the System Usability Scale .
Time Frame: 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.
|
Month 6
|
|
Detection of hypertension, based on transmitted BP values and in-clinic measurements
Time Frame: 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
|
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
Time Frame: 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
|
Throughout 6-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vanessa BEAU, Centre Hospitalier Côte Basque
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neoplasms
- Chronic Disease
- Disease Attributes
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Leukemia, B-Cell
- Lymphoma, B-Cell
- Lymphoma
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Leukemia, Lymphoid
- Leukemia
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Hypertension
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, Follicular
- Lymphoma, Mantle-Cell
- Waldenstrom Macroglobulinemia
- Lymphoma, B-Cell, Marginal Zone
Other Study ID Numbers
- P-2025/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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