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Heartbeat clues: could your pulse predict IBD drug success?

NCT ID NCT07475052

Knowledge-focused Sponsor: Xijing Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether continuous heart rate variability (HRV) monitoring can predict how well patients with inflammatory bowel disease (IBD) respond to biologic therapies like infliximab or vedolizumab. Researchers will track HRV in 100 patients starting treatment and compare those who respond versus those who don't at 14 weeks. The goal is to find a simple, non-invasive way to personalize IBD treatment early on.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict which IBD patients will benefit from biologic drugs like infliximab or vedolizumab, avoiding ineffective treatments.
What could go wrong
This is an early observational study with only 100 participants, so results may not apply to all patients. The link between heart rate variability and treatment response is still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.).

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease insomnia ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biologics Heart rate variability Inflammatory bowel disease Prediction Sleep quality

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xijing Hospital

    Xi'an, Shaanxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.