Acute Heart FailureNCT00561483
Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure
An observational study of Acute Heart Failure and Renal Failure, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Renal Failure
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2007to 14 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital with decompensated heart failure
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Heart Failure, Renal Failure
- Keywords
- Acute heart failure, cystatin C, renal failure, biomarker
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Patients admitted to the hospital with decompensated heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (2)
To determine the predictive value of changes in sequential cystatin C levels to subsequent development of WRF
To examine the natural history of cystatin C levels during diuretic therapy in ADHF
Measured: 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
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study start5 Dec 2007
- Primary completionDec 2013
- Study completion14 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
- Investigators
- W. H. Wilson Tang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561483
- Sponsor's protocol ID
- 07-834
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2007
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure
- ClinicalTrials.gov ID
- NCT00561483
- Acronym / sponsor ID
- 07-834
- Conditions
- Acute Heart Failure, Renal Failure
- Keywords
- Acute heart failure, cystatin C, renal failure, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 5 Dec 2007 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients admitted to the hospital with decompensated heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital with decompensated heart failure
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To examine the natural history of cystatin C levels during diuretic therapy in ADHF
Time frame: 7 days
To examine the natural history of cystatin C levels during diuretic therapy in ADHF
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. H. Wilson Tang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Renal Failure, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the natural history of cystatin C levels during diuretic therapy in ADHF (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.