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Feasibility study protocol for the evaluation of home blood pressure in patients receiving angiogenesis inhibitor
Kaori Kitaoka1,2, Satoshi Morimoto3,4, Shintaro Minegishi5
1Shiga University of Medical Science, NCD Epidemiology Research Center, Shiga, Japan.
Abstract:
Elevated blood pressure is frequently observed during cancer treatment with vascular endothelial growth factor inhibitors, reflecting either a treatment-emergent adverse event or pharmacological effect. Appropriate blood pressure management is critical in minimizing cardiovascular risk and prevent treatment interruption. Although home blood pressure monitoring is recommended to detect masked or white-coat hypertension, longitudinal data on home blood pressure trajectories during therapy remain limited. This multicenter observational pilot study aims to evaluate the association between clinic and home blood pressure in patients with malignant tumors receiving vascular endothelial growth factor inhibitors, and to assess factors associated with blood pressure variability and the feasibility of home monitoring during therapy. Approximately 50 participants are being enrolled. Home blood pressure is measured twice daily throughout the treatment period, and clinical, laboratory, and treatment-related data and patient-reported data are collected at baseline, during therapy, and at follow-up. The primary outcome is the difference between clinic and home blood pressures at multiple time points during and after vascular endothelial growth factor inhibitor therapy. Blood pressure phenotypes will be classified according to clinic and home blood pressure thresholds, and their clinical characteristics will be compared. Longitudinal trajectory of home blood pressure will be assessed to explore patterns associated with clinical outcomes. This study will clarify the relationship between clinic and home blood pressure, explore factors influencing blood pressure variability, and provide preliminary evidence on the feasibility and clinical value of home blood pressure monitoring in patients receiving angiogenesis inhibitor therapy.
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