Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

Completed

Conditions studied: Acute Heart Failure, Renal Failure

In brief

Renal Compromise after treatment of decompensated heart failure with diuretics is not uncommon. The purpose of our study is to investigate the relationship between cystatin C and worsening renal function in this setting. Cystatin C is a biomarker produced at a constant rate by all cells that is a sensitive biomarker of renal function.Cystatin C and Plasma amino terminal proB-type natriuretic peptide (NT-proBNP) levels will be obtained at baseline and daily. Our goal is to enroll 100 subjects with an estimated 5 samples per each subject. The time course of changes in cystatin C in relation to serum creatinine levels over time will be plotted. Our hypothesis is that sequential changes in cystatin C levels following initial treatment with diuretic therapy in the setting of acute decompensated heart failure may provide early insight into cardio-renal compromise. Understanding the natural history and time course of the changes in sequential cystatin C levels may facilitate further studies to guide the judicious use of diuretic therapy in acute decompensated heart failure, and to predict the risk of subsequent development of worsening renal function. If serial testing of cystatin C can provide accurate assessment and prediction of worsening renal function, clinical applications of these observations can be evaluated in future prospective studies.

Key facts

Study ID

NCT00561483

Run by

The Cleveland Clinic

People needed

64

Starts

2007-12-05

Expected to finish

2016-10-14

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospital admission within 48 hours for ADHF, with an expected stay over 24 hours.
• Evidence of fluid overload, including jugular venous distention, pulmonary rales, peripheral edema, and/or ascites receiving diuretic therapy

You may not qualify if…

• Heart failure due to congenital heart disease or critical aortic stenosis (potentially different cardio-renal pathophysiology)
• Acute myocardial infarction or unstable acute coronary syndromes
• End-stage renal insufficiency on renal replacement therapy (already has underlying advanced renal failure).
• Patients with active cancer (cystatin C has been shown to be produced by some tumors)
• Known exposure to nephrotoxic agents (such as contrast dye) or planned surgery during hospitalization at the time of enrollment
• Hemoglobin < 9 mg/dL or clinically significant active bleeding.
• Unable to comply with protocol or unable to have informed consent

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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