Heart FailureNCT02368041
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
An observational study of Heart Failure, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- InSpectraTM StO2 monitor
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 10 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Stable Heart failure patients under 25 years of age with a diagnosis of cardiomyopathy, myocarditis or univentricular palliation for congenital heart disease in a primary pediatric cardiologist office
Who may be able to join
- 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.
Who cannot join
- Patients presenting with acute deterioration in clinical status
- Patients with active infection
- Patients with autoimmune vasculitis disorder
- Patients with limb deformities and painful disorders of extremities
- Patients with underlying bone disorders, (e.g. osteogenesis imperfecta)
- Patients with severe anemia (Hb <7g/dL)
- Patients with peripheral vascular disease which can alter the microcirculation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Dipankar Gupta, MD, 352-273-7770, dgupta@ufl.edu
Dipankar Gupta, MD
About this 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.
Read the detailed description
Heart failure patients seen in the Pediatric Cardiology Congenital Heart Center will be enrolled into the study after obtaining informed consent on the day of their evaluation. The primary pediatric cardiologist following the patient will evaluate the need for regular investigations like blood work, electrocardiogram and echocardiogram. The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure the baseline StO2 level 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. Similar measurements will be obtained from an otherwise healthy cohort of children who present to the Pediatric Cardiology Congenital Heart Center for evaluation of a heart murmur or chest pain. The patient's treating physician and care providers will be blinded to the study test results. All clinical care will be at the discretion of the patient's treating physicians. Only StO2 levels will be obtained using the non-invasive probe placed on the thenar eminence for the purpose of the study.
- Conditions
- Heart Failure
- Being tested
- InSpectraTM StO2 monitor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSpectraTM StO2 monitorDevice
InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. to measure the baseline StO2 level 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 instantaneously and the rate of reperfusion (Rres; % × sec-1) will be measured. The measurement will be continued until the StO2 returns to the baseline value.
| Study group | Role | What they receive |
|---|---|---|
| InSpectraTM StO2 | InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. to measure the baseline StO2 level 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 instantaneously and the rate of reperfusion (Rres; % × sec-1) will be measured. The measurement will be continued until the StO2 returns to the baseline value. Receives: Device: InSpectraTM StO2 monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline StO2 percentage
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
Measured: Day 1
Secondary outcomes (2)
Occlusion- rate of desaturation (Rdes) of StO2 levels
After a stable baseline 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 for 3 min or until the StO2 level comes to zero (whichever is earlier).
Measured: Day 1
Recovery- rate of reperfusion (Rres) of StO2 levels
After 3 minutes from occlusion 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 for approximately 3 min.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion10 Dec 2026 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dipankar Gupta, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368041
- Sponsor's protocol ID
- IRB202200657
- Other IDs
- IRB201400800
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2015
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant will not be shared to avoid risk of loss of confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02368041
- Acronym / sponsor ID
- IRB202200657
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure patients seen in the Pediatric Cardiology Congenital Heart Center will be enrolled into the study after obtaining informed consent on the day of their evaluation. The primary pediatric cardiologist following the patient will evaluate the need for regular investigations like blood work, electrocardiogram and echocardiogram. The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure the baseline StO2 level 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. Similar measurements will be obtained from an otherwise healthy cohort of children who present to the Pediatric Cardiology Congenital Heart Center for evaluation of a heart murmur or chest pain. The patient's treating physician and care providers will be blinded to the study test results. All clinical care will be at the discretion of the patient's treating physicians. Only StO2 levels will be obtained using the non-invasive probe placed on the thenar eminence for the purpose of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InSpectraTM StO2 | – | Device: InSpectraTM StO2 monitorInSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. to measure the baseline StO2 level 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 instantaneously and the rate of reperfusion (Rres; % × sec-1) will be measured. The measurement will be continued until the StO2 returns to the baseline value. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Stable Heart failure patients under 25 years of age with a diagnosis of cardiomyopathy, myocarditis or univentricular palliation for congenital heart disease in a primary pediatric cardiologist office
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients presenting with acute deterioration in clinical status
- Patients with active infection
- Patients with autoimmune vasculitis disorder
- Patients with limb deformities and painful disorders of extremities
- Patients with underlying bone disorders, (e.g. osteogenesis imperfecta)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InSpectraTM StO2 monitorInSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. to measure the baseline StO2 level 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 instantaneously and the rate of reperfusion (Rres; % × sec-1) will be measured. The measurement will be continued until the StO2 returns to the baseline value. | Device | InSpectraTM StO2 |
Primary outcome
Baseline StO2 percentage
Time frame: Day 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
2 secondary outcomes
Occlusion- rate of desaturation (Rdes) of StO2 levels
Time frame: Day 1
Recovery- rate of reperfusion (Rres) of StO2 levels
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant will not be shared to avoid risk of loss of confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dipankar Gupta, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dipankar Gupta, MD (352-273-7770, dgupta@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline StO2 percentage (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.