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MediBeacon Transdermal GFR System for Heart Failure

This study is testing a new way to measure kidney function (glomerular filtration rate or GFR) in adults with heart failure. It uses a system called MediBeacon Transdermal GFR System along with an intravenous (IV) injection of Lumitrace. Researchers want to see how well this new method compares to the standard way of measuring GFR using plasma clearance after an IV injection of Iohexol. The main goal is to find out if the transdermal GFR measurement matches the standard GFR measurement. The study plans to enroll 15 participants and is currently recruiting. You may be able to join if you are 18 years or older, and meet specific contraception requirements if you are a woman who can become pregnant or a man.

Study design
This is an interventional study with an unspecified phase, aiming to enroll 15 participants. It compares a new transdermal measurement system to a standard method.
What's involved
You will have a screening visit within 15 days of the main study day. On the main study day, you will receive IV injections of Lumitrace and Iohexol, and a sensor will be placed on your chest to collect data.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, correlation of transdermal GFR to plasma-derived GFR, is measured on Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07349797

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure

Recruiting
NAAges 18+Interventional
MediBeacon
~15 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:LumitraceMediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR)Iohexol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)
Measured over Day 1

Conditions

Glomerular Filtration Rate
Heart Failure

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Heart Failure

NCT07349797

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University

    New York, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Richard B Dorshow, PhD · STUDY_DIRECTOR · MediBeacon, Inc.

Who to contact

Richard B Dorshow, PhD
[email protected]
314-735-0968
Email the study team

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Eligibility criteria

Inclusion

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

What this trial measures

  • Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)Day 1

    The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR across all participants. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) will be calculated with a double-sided 95% confidence interval (CI). The performance goal is 0.75, and success for the study is defined as a lower limit of the 95% CI greater than 0.75.