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Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00561483
First received: November 20, 2007
Last updated: January 5, 2017
Last verified: January 2017
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure

Resource links provided by NLM:


Further study details as provided by Wilson Tang, The Cleveland Clinic:

Primary Outcome Measures:
  • To examine the natural history of cystatin C levels during diuretic therapy in ADHF [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Serum

Enrollment: 64
Study Start Date: November 2007
Study Completion Date: October 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Patients admitted to the hospital with decompensated heart failure

Detailed Description:

This is a single-center, prospective, cohort study. The design of this pilot study focuses on the feasibility to complete the project in a short period of time by the applicant. Subjects will be identified in the morning after their hospital admission and informed consent will be obtained for the study. At the time of enrollment blood samples and urine samples will be collected as baseline, together with a brief history and physical examination to document degree of congestion and basic vital signs. In addition their unused (to be discarded) blood samples from previous clinical labs from this admission may be retrieved from the clinical laboratory.

Patients will be followed daily, and each day a blood draw and urine sample will be obtained for research purposes until the day of discharge. Changes in vital signs, available laboratory data for serum creatinine and BUN, and congestion score will be documented. Physicians treating the patient will be blinded from the laboratory results. Because of the small sample size and the low anticipated rate of adverse events, this study uses a combined outcome of either death in hospital, death within 90 days after discharge or readmission to the hospital facility for heart failure within 90 days. Patients will be called after 90 days for follow up if readmission or death information is not available in the Electronic Medical Record.

Specific aims include:

Specific Aim 1 - To examine the natural history of changes in sequential cystatin C levels during diuretic therapy in Acute Decompensated Heart Failure.

Specific Aim 2 - To determine the predictive value of changes in sequential cystatin C levels to subsequent development of worsening renal function (WRF) and WRF in association with aminoterminal pro B-type natriuretic peptide (NT-proBNP) levels.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: W. H. Wilson Tang, MD The Cleveland Clinic
  More Information

Responsible Party: Wilson Tang, Principal Investigator, staff cellular and molecular medicine and cardiovascular medicine, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00561483     History of Changes
Other Study ID Numbers: 07-834
Study First Received: November 20, 2007
Last Updated: January 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wilson Tang, The Cleveland Clinic:
Acute heart failure
cystatin C
renal failure
biomarker

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Cystatins
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017