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Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00561483
First received: November 20, 2007
Last updated: June 21, 2011
Last verified: June 2011

November 20, 2007
June 21, 2011
November 2007
December 2012   (final data collection date for primary outcome measure)
To examine the natural history of cystatin C levels during diuretic therapy in ADHF [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To examine the natural history of cystatin C levels during diuretic therapy in ADHF [ Time Frame: 7 days ]
Complete list of historical versions of study NCT00561483 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To determine the predictive value of changes in sequential cystatin C levels to subsequent development of WRF [ Time Frame: 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 [ Time Frame: 90 days ]
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Not Provided
 
Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure
Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Serum

Probability Sample

Patients admitted to the hospital with decompensated heart failure

  • Acute Heart Failure
  • Renal Failure
Not Provided
Observation
Patients admitted to the hospital with decompensated heart failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Wilson W.H. Tang, MD 216-444-2121 Tangw@ccf.org
United States
 
NCT00561483
07-834
No
Dr W H Wilson Tang, Cleveland Clinic
The Cleveland Clinic
Not Provided
Not Provided
The Cleveland Clinic
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP