Heart Failure Clinical Trial
Official title:
Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) in Patients Hospitalized for Volume Overload Decompensated Chronic Heart Failure
NCT number | NCT04019314 |
Other study ID # | 18-000181 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 11, 2019 |
Est. completion date | October 6, 2021 |
Verified date | August 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers are observing the values of proEnkephalin (PENK) via a blood draw in hospitalized patients that are volume overloaded requiring diuresis. If changes in PENK are found, physicians may predict values of change in kidney function during treatment.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 6, 2021 |
Est. primary completion date | October 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - LVEF <50% measured within 6 months of index hospitalization - Clinically identified volume overload with at least one sign of volume overload (pre-admission fluid weight gain, edema, increased DOE, PND, orthopnea, JVD on examination) and a need for intravenous diuretic therapy Exclusion Criteria: - Baseline sCr >3.0mg/dL and K+ <3.0 and >5.5mEq/L - Hemoglobin < 9.0g/dL - Systemic systolic blood pressure consistently <100mm Hg - Patients being treated with hemodialysis, CKD stage 5 or s/p renal transplantation - S/P cardiac transplant or LVAD implantation/total artificial heart - Pregnancy or of child bearing potential - Allergy to iodine - Unable to provide informed consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Sphingotec GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of ProEnkephalin to detect acute kidney injury in hospitalized to identify baseline values of PENK biomarkers of AKI in relation to measured intravascular volume. | Blood samples obtained during admission will be assessed for PENK biomarkers. Samples will be stored from all subjects for future analysis if PENK is supportive of a trend based on the PENK data. | Hospital admission through hospital discharge, approximately 6 days |
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