Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)

Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) in Patients Hospitalized for Volume Overload Decompensated Chronic Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Decompensated Heart Failure; Systolic Heart Failure; Volume Overload
• Intervention / Treatment: Procedure: Blood Collection; Procedure: Blood Volume Analysis

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subjects with know chronic systolic heart failure; Subjects with know chronic systolic heart failure (LVEF<50%) admitted to SMH Heart Failure Medical Service for decompensated HF with clinical findings of volume overload requiring advanced diuretic therapy intervention and management will receive daily blood draws and quantitative blood volume analysis	Procedure: Blood Collection; Samples for proEnkephalin PENK will be obtained daily and aliquots of these samples will be stored for later batch assays.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Sphingotec GmbH
• Investigators: Principal Investigator: Wayne Miller, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2019
• Primary Completion (ACTUAL): October 6, 2021
• Study Completion (ACTUAL): October 6, 2021

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heart Failure; Acute Kidney Injury; Heart Failure, Systolic
• Other Study ID Numbers: 18-000181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No