Sticker on chest could replace needles for kidney checks in heart failure
NCT ID NCT07349797
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests a new device that uses a sensor placed on the chest to measure kidney function in 15 adults with heart failure. Participants receive an injection of a fluorescent dye (Relmapirazin) and a standard contrast agent (iohexol), then the sensor tracks how quickly the dye clears from the skin. Researchers compare these readings to traditional blood tests to see if the sensor is accurate enough for routine use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Relmapirazin (Lumitrace) injection and iohexol
- What this could lead to
- If successful, this could provide a simpler, less invasive way to monitor kidney function in heart failure patients, reducing the need for repeated blood draws.
- What could go wrong
- This is a very small, early study with only 15 participants, so results may not apply to everyone. The sensor's accuracy may not meet the target, and it is not a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years; 1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial 2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose 3. For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization 4. Men will not donate sperm during the study and for 1 month following the last dose of study drug. 2. Diagnosis of symptomatic heart failure: Subject has symptomatic heart failure, ACC/AHA Stage C or D, ambulatory or hospitalized for heart failure, adjudicated by a principal investigator, and meeting both of the following: 1. Clinical syndrome: Symptoms and/or signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and 2. Objective evidence of heart failure (≥1 of): * Left ventricular systolic dysfunction or other structural abnormalities (left atrial enlargement, left ventricular hypertrophy, diastolic dysfunction on echocardiography) or * Hemodynamic evidence of elevated filling pressures by invasive or noninvasive assessment, or * Elevated natriuretic peptides obtained within 90 days from enrollment: NT-proBNP ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm or NT-proBNP ≥900 pg/mL (BNP ≥300 pg/mL) in atrial fibrillation 3. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol 4. Adequate venous access sufficient to allow blood sampling per protocol requirements Exclusion Criteria: To be eligible for the study, participants must not meet any of the criteria noted below: 1. Intolerance to iohexol or iodine allergy 2. Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products 3. Administration of iohexol for cross-sectional imaging within a week from the dosing visit 4. Limb amputation 5. Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease) 6. Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit 7. Clinical signs of excessive volume overload (edema grade 3-4 or ascites) 8. Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings 9. Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day 10. Use of make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing 11. Participants who have received nephrotoxic agent or signs or symptoms suggestive of a condition that may result in acute kidney injury within two weeks of study entry.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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