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ENROLLING BY INVITATION
NCT07475052

Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Continuous Heart Rate Variability Monitoring for Predicting Response to Biologic Therapy in Inflammatory Bowel Disease: A Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-12-25

Completion Date

2027-10-01

Last Updated

2026-03-16

Healthy Volunteers

No

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China