Observational Study of Thenar NIRS in Pediatric Heart Failure

This observational study is looking at how a non-invasive device, the InSpectraTM StO2 monitor, measures oxygen levels in the hand (thenar eminence) of children with heart failure. The study aims to understand the baseline oxygen saturation (StO2) in these patients. You might be able to join if you are under 25 years old, have heart failure due to cardiomyopathy, myocarditis, or univentricular palliation for congenital heart disease, and are stable on your current medical treatment. The study is currently enrolling participants, with a goal of 130 patients.

Study design
This is a single-center, non-randomized observational study. It aims to enroll 130 participants.
What's involved
You would have a non-invasive probe placed on your hand to measure oxygen levels, followed by a blood pressure cuff inflation and release to measure changes in oxygen. This would happen on the day of your evaluation.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for this study is taken on Day 1.

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NCT02368041

Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure

Recruiting
Not specifiedUp to 25Observational
University of Florida
~130 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:InSpectraTM StO2 monitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline StO2 percentage
Measured over Day 1
Heart Failure
1 sites across 1 states
Florida1
  • Dipankar Gupta, MD · PRINCIPAL_INVESTIGATOR · University of Florida

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Eligibility criteria

Inclusion

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.
  • Baseline StO2 percentageDay 1

    The study staff will use the InSpectraTM StO2 monitor manufactured by Hutchinson Technology to measure the baseline StO2 level after applying the noninvasive probe to the thenar eminence