Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

NCT00561483 | Completed

• 1 other identifier: 07-834
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Heart Failure; Renal Failure

Keywords

Acute heart failure; cystatin C; renal failure; biomarker

Outcome Measures

Primary Outcomes (1)

• To examine the natural history of cystatin C levels during diuretic therapy in ADHF

  To examine the natural history of cystatin C levels during diuretic therapy in ADHF

  7 days

Secondary Outcomes (2)

• To determine the predictive value of changes in sequential cystatin C levels to subsequent development of WRF

  7 days

• The combined outcome of either death in hospital or death within 90 days after discharge or readmission to the hospital facility for heart failure within 90 days

  90 days

Study Arms (1)

Observation

Patients admitted to the hospital with decompensated heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the hospital with decompensated heart failure

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• W. H. Wilson Tang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, staff cellular and molecular medicine and cardiovascular medicine

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: December 5, 2007
• Primary Completion: December 1, 2013
• Study Completion: October 14, 2016
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)