Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019314
• Other study ID #: 18-000181
• Status: Completed
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: October 6, 2021

Study information

• Verified date: August 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The purpose of this study will be to probe if values of proEnkephalin, called PENK in this proposal, can identify those patients who develop AKI. This biomarker is an opioid that is rapidly released in response to renal injury. At a cut-off value of 100pmol/L, it has been reported to have excellent sensitivity and specificity for detecting renal injury. PENK has been shown to be prognostic of WRF and outcomes in patients with acute heart failure but requires evaluation of efficacy in detecting AKI in standard of care clinical practice settings. In this study we propose to evaluate the baseline presence of plasma and/or serum levels of biomarkers of renal injury and changes in these biomarkers during the course of in-hospital intravenous diuretic therapy. The question is if threshold values of the biomarkers can be identified and if those threshold values would indicate a clinically significant change in renal function that would warrant a change in diuretic therapy to occur. In this context the quantitative assessment of intravascular volume will provide objective corroboration as to volume status in relation to biomarker levels and changes during treatment. If this approach can be proven to be fruitful, it would be anticipated that a subsequent study, a clinical trial, to test the hypothesis that biomarkers of AKI, specifically PENK, could be used to identify and avoid AKI in hospitalized patients with decompensated HF.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Decompensated Heart Failure
• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure
• Volume Overload

Intervention

Procedure:
• Blood Collection
Samples for proEnkephalin PENK will be obtained daily and aliquots of these samples will be stored for later batch assays.
• Blood Volume Analysis
A small amount of a radioactive isotope or tracer is injected and blood samples are taken at 6 time points during the test and analyzed.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Sphingotec GmbH

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials