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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.