MediBeacon transdermal GFR test in adults with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the MediBeacon transdermal GFR (tGFR) system combined with Lumitrace and iohexol to measure kidney function in adults with symptomatic heart failure. Participants receive Lumitrace and iohexol, wear a reusable chest sensor, and have ongoing tGFR readings collected over 10–24 hours, with comparison to traditional nGFRBSA measurements. The study includes a screening visit within 15 days of dosing and follow-up by phone after completion. Primary goals are to determine accuracy and feasibility of the transdermal approach and to characterize its performance across participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Richard B Dorshow, PhD
• Email: rbdorshow@medibeacon.com
• Phone: 314-735-0968

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.