An interventional study of Blood Collection and Blood Volume Analysis in Heart Failure, Volume Overload and Decompensated Heart Failure, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Screening
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.
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Procedure: Blood Volume Analysis
Samples for proEnkephalin PENK will be obtained daily and aliquots of these samples will be stored for later batch assays.
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.
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.
Time frame: Hospital admission through hospital discharge, approximately 6 days
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic