Status:
COMPLETED
FAST PV and mGFR™ Technology in Congestive Heart Failure
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
FAST BioMedical
Conditions:
CHF
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
Detailed Description
This investigator-initiated, one-armed study is designed to evaluate the safety and function of the FAST PV and mGFR Technology in patients with CHF. Data from the FAST PV and mGFR Technology will not...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- New or ongoing myocardial infarction or unstable angina present at the time of planned study inclusion.
- 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).
- Patient is legally detained in an official institution.
- Patient is dependent on the sponsor, the investigator, or the trial sites.
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03808948
Start Date
January 10 2019
End Date
August 17 2019
Last Update
November 17 2021
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353