Continuous Heart Rate Variability Monitoring for Predicting Response to Biologic Therapy in Inflammatory Bowel Disease: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
结局指标
主要结局
Disease activity
时间窗: 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.
Heart Rate Variability
时间窗: 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.
次要结局
- Sleep Monitoring(During 14 weeks of treatment.)
- Pittsburgh Sleep Quality Index (PSQI)(At baseline, Week 6, and Week 14.)
- Insomnia Severity Index (ISI)(At baseline, Week 6, and Week 14.)
- Flinders Fatigue Scale (FFS)(At baseline, Week 6, and Week 14.)
- Generalized Anxiety Disorder-7 (GAD-7)(At baseline, Week 6, and Week 14.)
- Patient Health Questionnaire-9 (PHQ-9)(At baseline, Week 6, and Week 14.)
- Therapeutic drug monitoring(Week 14.)
- Fecal calprotectin (FC)(At baseline and Week 14.)