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Sticker on chest could replace needles for kidney checks in heart failure

NCT ID NCT07349797

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

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