Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

March 11, 2026 updated by: Xijing Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with IBD aged 18-75 years who initiate IFX or VDZ treatment for the first time will be recruited from Xijing hospital, Tang-Du hospital and Air Force 986 Hospital.

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: At baseline, Week 2, Week 6, and Week 14.
The SCCAI score was used to assess clinical disease activity in patients with ulcerative colitis (UC). Clinical response was defined as a reduction in the SCCAI score of ≥3 points from baseline; clinical remission was defined as an SCCAI score ≤2 points. The HBI score was used to assess clinical disease activity in patients with Crohn's disease (CD). Clinical response was defined as a reduction in the HBI score of ≥3 points from baseline; clinical remission was defined as an HBI score ≤4 points.
At baseline, Week 2, Week 6, and Week 14.
Heart Rate Variability
Time Frame: At baseline, Week 2, Week 6, and Week 14.
A patch-type dynamic electrocardiogram recorder is used to detect HRV. This product is suitable for collecting, monitoring, and storing three-lead dynamic electrocardiogram signals in adults and can be worn continuously. HRV parameters are obtained through continuous 72-hour dynamic ECG data acquisition.
At baseline, Week 2, Week 6, and Week 14.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Monitoring
Time Frame: During 14 weeks of treatment.
Smart wearable sleep tracking devices (Huawei Band 10) are used for complementary sleep monitoring. Key parameters to be measured include total sleep time, wake after sleep onset and sleep architecture.
During 14 weeks of treatment.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline, Week 6, and Week 14.
PSQI is used to evaluate the sleep quality of the subjects in the last 1 month. There are 7 dimensions and 9 entries with a total score between 0 and 21, where a score higher than 5 indicates a sleep quality problem, 0 to 5 indicates good sleep quality, 6 to 10 indicates moderate sleep quality, 11 to 15 indicates poor sleep quality, and 16 to 21 indicates very poor sleep quality.
At baseline, Week 6, and Week 14.
Insomnia Severity Index (ISI)
Time Frame: At baseline, Week 6, and Week 14.
The ISI is used to evaluate the severity of insomnia in patients, primarily evaluating sleep problems over the past two weeks and their impact on quality of life. The scale consists of seven items, each rated on a 5-point scale (0 = none, 4 = very severe), with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia, where 0-7 points indicate no clinically significant insomnia, 8-14 points indicate subthreshold insomnia, 15-21 points indicate moderate clinical insomnia, and 22-28 points indicate severe clinical insomnia.
At baseline, Week 6, and Week 14.
Flinders Fatigue Scale (FFS)
Time Frame: At baseline, Week 6, and Week 14.
The FFS is a brief self-rated questionnaire specifically designed to assess daytime fatigue associated with insomnia, commonly used for rapid screening of patients' fatigue levels. The scale comprises 7 items, primarily measuring fatigue characteristics over the past two weeks. The first six items are scored from 0 (not at all) to 4 (extremely severe), while the time period item is scored based on the number of time periods checked (1 point per time period). All item scores are summed to obtain the total score, which typically ranges from 0 to 31, with higher scores indicating greater severity of fatigue.
At baseline, Week 6, and Week 14.
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: At baseline, Week 6, and Week 14.
The GAD-7 is used to evaluate the symptoms and severity of anxiety in patients. It includes 7 entries, each with a score of 0 to 3 and a total score between 0 and 21. Higher scores indicate greater anxiety severity. The commonly used classification criteria are as follows: 0-4 points (no or minimal anxiety), 5-9 points (mild anxiety), 10-14 points (moderate anxiety), and 15-21 points (severe anxiety). A total score of 10 or higher is generally indicated the possible presence of an anxiety disorder.
At baseline, Week 6, and Week 14.
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: At baseline, Week 6, and Week 14.
The PHQ-9 is used to assess the symptoms and severity of depression in patients. It consists of nine main entries, each with a score of 0 to 3 and a total score between 0 and 27. The score is generally used to determine the severity of depression: 0-4 points indicate no depression, 5-9 points indicate mild depression, 10-14 points indicate moderate depression, 15-19 points indicate moderately severe depression, and 20 or higher points indicate severe depression.
At baseline, Week 6, and Week 14.
Therapeutic drug monitoring
Time Frame: Week 14.
All patients will undergo measurement of drug trough concentrations for IFX and VDZ at Week 14 of treatment. The concentration testing will be performed within 24 hours prior to the next scheduled infusion (i.e., close to the time of drug administration).
Week 14.
Fecal calprotectin (FC)
Time Frame: At baseline and Week 14.
FC is a widely used biomarker in the assessment and management of iIBD. As a stable protein released by activated neutrophils during intestinal inflammation, FC can effectively reflect the degree of mucosal inflammation non-invasively; elevated FC levels correlate with active intestinal inflammation, helping to distinguish between inflammatory bowel disease and functional gastrointestinal disorders such as irritable bowel syndrome. It also plays an important role in monitoring disease activity, evaluating treatment response, detecting early mucosal recurrence, and supporting clinical decision-making in patients with IBD.
At baseline and Week 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tang-Du Hospital
Air Force 986 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20252534

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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