Menu
Enrolling by invitation NCT07475052

Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

— Observational Inflammatory Bowel Disease Heart Rate Variability Biologics Prediction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease, Heart Rate Variability, Biologics, Prediction. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Disease activity [Time frame: At baseline, Week 2, Week 6, and Week 14.]
  • Heart Rate Variability [Time frame: At baseline, Week 2, Week 6, and Week 14.]
Secondary outcome measures (8)
  • Sleep Monitoring [Time frame: During 14 weeks of treatment.]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: At baseline, Week 6, and Week 14.]
  • Insomnia Severity Index (ISI) [Time frame: At baseline, Week 6, and Week 14.]
  • Flinders Fatigue Scale (FFS) [Time frame: At baseline, Week 6, and Week 14.]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: At baseline, Week 6, and Week 14.]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: At baseline, Week 6, and Week 14.]
  • Therapeutic drug monitoring [Time frame: Week 14.]
  • Fecal calprotectin (FC) [Time frame: At baseline and Week 14.]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xijing Hospital — Xi'an

Identifiers

NCT: NCT07475052 · KY20252534

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗