Heart rate variability measurement to assess disease activity in patients with Crohn's disease, a cross-sectional study

Completed

• Conditions: Crohn's disease; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON42566
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Patients 18-80 years old, either female or male
Active CD/inactive CD
Indication for endoscopy (disease evaluation)
BMI range between 17.5 and 30 kg/m2

Exclusion Criteria

Comorbidity
- Cardiac arrhythmias, Hyper-, Hypotension, Peripheral vascular disease, Diabetic mellitus
- Splenectomy
- Infectious diseases: acute or chronic infections
- Depression
- Kidney failure
- Pulmonary diseases: upper- and lower respiratory diseases, Asthma
Medication
- Short- and Long acting Beta-agonist
- Beta 1 and 2 -blocker
- Alpha 1 and 2- blocker
Alcohol, Caffeine (last 24hrs)
Any type of cancer

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective will be to correlate endoscopic disease activity, measured<br /><br>by SES-CD, with (the change in) HRV.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As a second outcome we aim to investigate the Harvey Bradshaw index (HBI),<br /><br>serum CRP, white blood cells (WBC), faecal Calprotectin and urinary<br /><br>metanephrines in comparison to the HRV.</p><br>