Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.

NCT Number	NCT07475052
Lead Sponsor	Xijing Hospital Collaborators: Tang-Du Hospital, Air Force 986 Hospital
Conditions	Inflammatory Bowel Disease, Heart Rate Variability, Biologics, Prediction, Sleep Quality
Enrollment	100 participants
Start Date	2025-12-25
Primary Completion	2027-10-01 (estimated)
Study Completion	2027-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-16