Measuring tissue oxygen levels in children with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate tissue oxygen saturation levels in pediatric patients with heart failure using a non-invasive InSpectraTM monitor. The study will measure baseline oxygen saturation in the thenar eminence and assess how these levels change during induced desaturation and reperfusion. The investigators hypothesize that heart failure in children leads to lower baseline oxygen saturation and altered desaturation and reperfusion rates, which may correlate with the severity of the condition. Healthy children will also be evaluated for comparison, while clinical care will remain at the discretion of the treating physicians.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Heart failure patients under 25 years of age with a diagnosis of cardiomyopathy, myocarditis or univentricular palliation for congenital heart disease who are stable on their medical management will be enrolled.

Exclusion Criteria:

1. Patients presenting with acute deterioration in clinical status
2. Patients with active infection
3. Patients with autoimmune vasculitis disorder
4. Patients with limb deformities and painful disorders of extremities
5. Patients with underlying bone disorders, (e.g. osteogenesis imperfecta)
6. Patients with severe anemia (Hb \<7g/dL)
7. Patients with peripheral vascular disease which can alter the microcirculation

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Dipankar Gupta, MD — University of Florida
• Study coordinator: Dipankar Gupta, MD
• Email: dgupta@ufl.edu
• Phone: 352-273-7770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.