Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure
| Tracking Information | |||||
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| First Received Date ICMJE | November 20, 2007 | ||||
| Last Updated Date | June 21, 2011 | ||||
| Start Date ICMJE | November 2007 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To examine the natural history of cystatin C levels during diuretic therapy in ADHF [ Time Frame: 7 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To examine the natural history of cystatin C levels during diuretic therapy in ADHF [ Time Frame: 7 days ] | ||||
| Change History | Complete list of historical versions of study NCT00561483 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure | ||||
| Official Title ICMJE | Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients admitted to the hospital with decompensated heart failure |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Observation
Patients admitted to the hospital with decompensated heart failure |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00561483 | ||||
| Other Study ID Numbers ICMJE | 07-834 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr W H Wilson Tang, Cleveland Clinic | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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