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The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure.
The main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement.
Participants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 130 mg Lumitrace/1.5 mL Iohexol | Experimental | Participants will have the tGFR sensor placed and background measurements initiated. Participants will then receive a single intravenous 130 mg dose of Lumitrace followed by 1.5 mL of iohexol. They will be followed at the study center for 10-24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumitrace | Device | 18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR) | 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. | Day 1 |
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Inclusion Criteria:
Age ≥18 years;
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):
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard B Dorshow, PhD | Contact | 314-735-0968 | rbdorshow@medibeacon.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard B Dorshow, PhD | MediBeacon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
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| MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR) | Device | Site staff will place and affix the tGFR reusable sensor and Disposable Ring for all enrolled participants. One sensor will be attached to the upper chest. An adhesive clip, surgical tape or other means may also be used to alleviate tension on the sensor cord. TGFR assessments will be collected for a minimum of 6 hours up to 8 hours post Lumitrace injection. |
|
| Iohexol | Drug | 1.5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 -60 seconds |
|
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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