Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD (NCT07475052) | Clinical Trial Compass
By InvitationNot Applicable
Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD
China100 participantsStarted 2025-12-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Diagnosed with UC according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 · Xi'an) or diagnosed with CD according to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023 · Guangzhou) at least 3 months before enrollment;
* Initiation of IFX or VDZ treatment for the first time based on actual clinical needs;
* Concomitant use of stable doses of 5-ASA or immunosuppressants is permitted;
* Able and willing to wear an HRV monitoring device and sign an informed consent form.
Exclusion Criteria:
* Patients receiving combination therapy with two or more biological agents;
* History of IBD-related surgery within the past 4 weeks or planned surgery during the study period;
* Current severe intestinal infection (e.g., uncontrolled Clostridium difficile or cytomegalovirus infection);
* Diagnosed extensive small bowel resection or short bowel syndrome;
* Uncontrolled psychiatric disorders (e.g., severe anxiety or depression) or use of anti-anxiety/depressant medications that may affect autonomic nervous function;
* Use of medications affecting heart rate or autonomic nervous function without the ability to maintain a stable dose during the trial (e.g., beta-blockers, calcium channel blockers, etc.);
* Coexisting conditions related to autonomic dysfunction (e.g., hyperthyroidism, thyroiditis, hypertension, various types of conduction blocks, arrhythmias, etc.).
What they're measuring
1
Disease activity
Timeframe: At baseline, Week 2, Week 6, and Week 14.
2
Heart Rate Variability
Timeframe: At baseline, Week 2, Week 6, and Week 14.