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

Inclusion criteria

• Age ≥18 years;
• Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial
• Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose
• 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
• Men will not donate sperm during the study and for 1 month following the last dose of study drug.
• 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:
• Clinical syndrome: Symptoms and/or signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and
• 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
• Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
• 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:
• Intolerance to iohexol or iodine allergy
• Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products
• Administration of iohexol for cross-sectional imaging within a week from the dosing visit
• Limb amputation
• Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)
• Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit
• Clinical signs of excessive volume overload (edema grade 3-4 or ascites)
• Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings
• Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day
• 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
• 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.