FAST PV and mGFR™ Technology in Congestive Heart Failure

NCT03808948 | Completed Results FDA Device

• 2 other identifiers: EmPaKt-CHF2018-002638-18
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated, one-armed, phase 2 clinical trial using an injectable fluorescent tracer to assay and evaluate measured plasma volume (mPV) and measured glomerular filtration rate (mGFR) in hospitalized patients with acute decompensated congestive heart failure (CHF).

Conditions

CHF

Keywords

congestive heart failure; glomerular filtration rate; plasma volume

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Related AEs and Serious Adverse Events (SAEs)

  The percentage of treatment emergent SAEs considered to be surely related to the VFI should be zero.

  30 days

• Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3

  Function of the FAST PV measurement will be assessed by determining the plasma stability of the FD003 high molecular weight marker over the 15, 30, and 60 minute blood draws and applying the following criteria: * The FAST PV measurement is considered as stable, if the mean plasma concentration of FD003 at 30 minutes is not more than 10% lower than the mean plasma concentration at 15 minutes AND if the mean plasma concentration at 60 minutes is not more than 10% lower than the mean plasma concentration at 30 minutes * We will determine the percentage of patients which show a decline in the plasma concentration of FD003 of more than 10% from 15min to 30min and separately from 30 min to 60min. This percentage should be ideally close to 0.

  3 days

Secondary Outcomes (6)

• Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV

  3 days

• Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV

  3 days

• Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR

  3 days

• Percentage of the Population That Developed Acute Kidney Injury (AKI) Within the Following 48-72 Hour and Prediction of AKI by mGFR/eGFR Ratio on Days 1 and 3

  48-72h

• Percentage of Patients Who Are Refractory to Diuretic Therapy

  5 days

Study Arms (1)

All Patients

EXPERIMENTAL

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

Device: VFI

Interventions

VFI DEVICE

The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study prior to any study-related measures present.
• Hospitalized patient with acute decompensated heart failure, diagnosed on the basis of the presence of at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of heart failure.
• ≥ 18 years of age.
• Male with female partners of childbearing potential give agreement to practice abstinence or use condoms from enrollment through 90 days after administration of the last dose of study drug present.
• Partner of a male patient: Agreement to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from enrollment through 90 days after administration of the last dose of study drug present.
• Male patient agrees to not donate sperm from enrollment through 90 days after administration of the last dose of study drug present.
• A female patient is eligible to enter the study if she is not pregnant or nursing; of non-childbearing potential (ie, post-menopausal defined as having been amenorrheic for at least 1 year prior to screening, or has had bilateral tubal ligation at least 6 months prior to administration of study drug or bilateral oophorectomy or complete hysterectomy); and if of childbearing potential, must have a negative urine or serum pregnancy test within 24 h prior to drug administration and be using a highly effective means of contraception during study participation and until 1 month after the last dose of study drug. Highly effective contraception methods include total abstinence or combination of any two of the following: (i) use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy; (ii) placement of an intrauterine device (IUD) or intrauterine system (IUS); and (iii) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
• Patient is able to communicate effectively with the study personnel.
• Patient is informed of the nature and risks of the study and give written informed consent prior to enrollment.

You may not qualify if:

• Patient shows evidence of severe infection other than pneumonia, or active internal bleeding (characterized by recent decrease of blood hemoglobin concentration by more than 2 g/dl).
• Patient experiences new onset atrial fibrillation.
• Patient has an elective surgery planned during the 30 days he/she is enrolled in the study.
• Patient has a psychiatric disease or a history of illicit drug use that would prohibit him/her from complying with study requirements.
• Prior exposure to VFI present.
• History of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to fluorescent dyes, or dextran molecules present.
• Patient requires intravenous vasodilators or inotropic agents (other than digoxin or digitoxin) for heart failure.
• Patient undergoes chronic dialysis (for example peritoneal or hemodialysis) treatments.
• Patient is in cardiogenic shock or on vasopressors.
• Hypotension as defined by blood pressure ≤ 90 mm Hg systolic and/or ≤ 50 mm Hg diastolic exists.
• Patient has significant non-cardiac disease of other organ system (eg, malignancies, significant neurological disease).
• Patient does not have a working telephone.
• Patient is pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
• Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial present.
• Patient has a participation in another interventional clinical trial during this study or within 30 days (or longer) before entry into this study (as a minimum; 5 x elimination half-life / terminal elimination of an investigational medicinal product).

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• FAST BioMedical: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

• Hinze C, Karaiskos N, Boltengagen A, Walentin K, Redo K, Himmerkus N, Bleich M, Potter SS, Potter AS, Eckardt KU, Kocks C, Rajewsky N, Schmidt-Ott KM. Kidney Single-cell Transcriptomes Predict Spatial Corticomedullary Gene Expression and Tissue Osmolality Gradients. J Am Soc Nephrol. 2021 Feb;32(2):291-306. doi: 10.1681/ASN.2020070930. Epub 2020 Nov 25.

  PMID: 33239393 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Dr. med. Kai Schmidt-Ott
• Organization: Charité - Universitätsmedizin Berlin

Kai.schmidt-ott@charite.de

+4930450614671

Study Officials

• Kai M Schmidt-Ott, Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 18, 2019
• Study Start: January 10, 2019
• Primary Completion: August 17, 2019
• Study Completion: August 17, 2019
• Last Updated: November 17, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)