Home › Heart Failure › NCT02368041

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

Who can join

Up to age 25 · All sexes · Healthy volunteers welcome

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

About the study

This is a single-center, non-randomized study.The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure baseline StO2 levels after applying the noninvasive probe to the thenar eminence. After a stable reading is obtained, a blood pressure cuff will be inflated 40 mmHg above the obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3 minutes or once the StO2 level comes to zero (whichever is earlier), the cuff pressure will be released and the rate of reperfusion (Rres; % × sec-1) will be measured. The investigators hypothesize that heart failure in children causes a baseline lower thenar tissue oxygen saturation (StO2), a faster rate of desaturation (Rdes) and a prolonged rate of reperfusion (Rres). The investigators also hypothesize that these changes will correlate with the severity of heart failure. The results of this study will provide groundwork for studies looking at correlation of therapy modification based on the combination thenar StO2 and clinical presentation.

What is being tested

• InSpectraTM StO2 monitor (device)

Sponsor: University of Florida · Participants: 130 · Started: 2015-05

Contact the study team

• Dipankar Gupta, MD · Phone: 352-273-7770

Official record on ClinicalTrials.gov — NCT02368041

Locations in the U.S.

Conditions

• Heart Failure

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.