ClinicalTrials.gov record NCT07592481
Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors
Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This pilot interventional study gives people starting oral covalent BTK inhibitors a validated connected blood pressure monitor, training, and daily remote monitoring by an Advanced Practice Nurse for six months. It measures how well participants follow the home BP schedule and collects data on detection and management of high blood pressure during follow-up.
What it is studying. The study tests adherence to a connected home blood pressure monitoring program over six months in patients starting covalent BTK inhibitors, and evaluates detection and subsequent management actions for BTKi-associated hypertension using transmitted and in-clinic BP readings.
What the researchers hope to learn. Scientific goals: measure adherence to recommended home BP measurements (primary outcome defined as ≥144 valid measurements in 6 months), assess patient usability/satisfaction (System Usability Scale), document detection of hypertension from transmitted and clinic readings, and record management actions (cardio-oncology consultations, initiation or change of antihypertensive treatment, and adjustments to BTKi therapy).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Connected home blood pressure monitoring with daily IPA supervision.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
You would receive a validated connected home blood pressure monitor and standardized training. The device sends readings automatically to a secure platform that an Advanced Practice Nurse (IPA) monitors daily; the nurse will check adherence and data quality and coordinate care if needed. You will have an initial IPA visit, a cardio‑oncology visit, a medication reconciliation visit, clinic visits at 1, 4, and 6 months, and scheduled phone calls (week 1, 2, 3, 6, month 3, and month 5). Participation requires keeping the device connected to the internet and providing written informed consent.
How the study is structured. Single-group interventional study with no masking: all participants receive a validated connected BP device, standardized training, and daily remote monitoring by an Advanced Practice Nurse (IPA). Scheduled clinic visits occur at inclusion and at months 1, 4, and 6; phone follow-up is planned at weeks 1, 2, 3, 6 and months 3 and 5. BP measurements are transmitted automatically to a secure platform and reviewed daily; total follow-up is six months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Jul 1, 2026 (estimated)
- Primary completion
- Dec 31, 2027 (estimated)
- Study completion
- Dec 31, 2027 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Jun 22, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Centre Hospitalier de la côte Basque
- Principal investigator
- Mme BEAU Vanessa, Study nurse
Centre Hospitalier de la côte Basque
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Séverine LABARRERE 📞 +33559443828 ✉ slabarrere@ch-cotebasque.fr
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- treatment-naive
- Has not previously received the treatment, or the type of treatment, that the study is about.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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