NCT07592481

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Dec 2027

First Submitted

Initial submission to the registry

May 5, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

May 5, 2026

Last Update Submit

June 18, 2026

Conditions

Chronic Lymphocytic Leukemia (CLL)Follicular Lymphoma ( FL)Mantle Cell LymphomaMarginal Zone B Cell LymphomaWaldenstrom MacroglobulinaemiaLymphoplasmacytic Lymphoma

Keywords

BTK inhibitorHypertensionTelemonitoringConnected deviceBlood pressureLymphoid malignanciesAdvanced practice nursingCardio-oncology

Outcome Measures

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)

    Month 6

Secondary Outcomes (3)

  • - Patient satisfaction, assessed using the System Usability Scale .

    Month 6

  • Detection of hypertension, based on transmitted BP values and in-clinic measurements

    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

    Throughout 6-month follow-up

Study Arms (1)

Connected home blood pressure monitoring with daily IPA supervision

EXPERIMENTAL
Device: Connected home blood pressure monitoring with daily IPA supervision.

Interventions

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.

Connected home blood pressure monitoring with daily IPA supervision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known cognitive impairment
  • No internet access
  • Individuals under guardianship, curatorship, or legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellHypertension

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, B-Cell

Study Officials

  • Vanessa BEAU

    Centre Hospitalier Côte Basque

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Séverine LABARRERE

CONTACT

+33559443828slabarrere@ch-cotebasque.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study nurse

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 18, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06