Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure - Full Text View

Sponsor:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00561483

Purpose

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.

Condition
Acute Heart Failure Renal Failure

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Kidney Failure

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

To examine the natural history of cystatin C levels during diuretic therapy in ADHF [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the predictive value of changes in sequential cystatin C levels to subsequent development of WRF [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Observation Patients admitted to the hospital with decompensated heart failure

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients admitted to the hospital with decompensated heart failure

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561483

Contacts

Contact: Wilson W.H. Tang, MD

216-444-2121

Tangw@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator:

Arash Aghel, MD

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic ( Dr W H Wilson Tang )
Study ID Numbers:	07-834
Study First Received:	November 20, 2007
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00561483 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

Acute heart failure
cystatin C
renal failure
biomarker

Additional relevant MeSH terms:

Heart Failure
Renal Insufficiency
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

Urologic Diseases
Cysteine Proteinase Inhibitors
Cardiovascular Diseases
Kidney Diseases
Cystatins
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010