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NCT07475052
Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD
trial in Inflammatory Bowel Disease in 100 participants. Enrolling by invitation.
1 October 2027
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 25 December 2025 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 October 2027 |
| Sites | 1 location across China |
Conditions studied
- Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
- Heart Rate Variability — all drugs for Heart Rate Variability →
- Biologics — all drugs for Biologics →
- Prediction — all drugs for Prediction →
Sponsor
Xijing Hospital
Who can join
Adults 18 to 75, any sex, with Inflammatory Bowel Disease or Heart Rate Variability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07475052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07475052 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital
- Last refreshed: 16 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07475052.
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