Biomarkers to Classify Heart Failure
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|ClinicalTrials.gov Identifier: NCT02347722|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Last Update Posted : January 7, 2019
|Condition or disease|
This is a cohort study consisting of 2 patient cohorts. The first cohort will be studied retrospectively, using existing blood samples from different biobanks. Biomarkers will be measured and matched with the etiology of previously diagnosed heart failure by a biomarker panel of heart failure experts. This cohort consists of 100 patients each with (1) ischemic cardiomyopathy, (2) dilated cardiomyopathy and (3) diastolic heart failure. Blood samples will be analyzed for novel biomarkers. Investigators will be seeking biomarker candidate(s) alone or in combination which can predict each category of heart failure etiology with over 85% accuracy and the lowest levels of reclassification. A panel of heart failure experts will be assembled, and the appropriate cut-off values determined. Once this goal has been achieved, the prospective study will go ahead.
In the second cohort, biomarkers will be measured and used to diagnose the etiology of heart failure for each subject. This diagnosis will then be compared to the diagnosis from results of the usual diagnostic tests. Investigators will recruit 450 patients admitted to hospital or outpatient clinics with recently diagnosed heart failure (<2 years) and test for different biomarkers. Using the biomarker values, investigators will predict their heart failure etiology in an objective manner. The patients will then undergo definitive etiological workup as usual to establish the actual etiology of the heart failure. The duration of a typical etiological workup is about 3 days for hospitalized patients and up to 8 weeks for patients admitted to outpatient clinics. The predictive accuracy of the new heart failure panel will be compared to clinical assessment.
Investigators will perform cost-modeling in terms of the potential savings in avoiding unnecessary coronary angiographies or perfusion scans in a typical mixed cohort of heart failure patients based on the marker determined etiology.
A group of healthy volunteers will be added. This group will serve as age matched controls to the prospective cohort of heart failure patients.
|Study Type :||Observational|
|Actual Enrollment :||511 participants|
|Official Title:||Evaluation of Existing Biomarker Candidates to Accurately Classify the Etiology of Heart Failure|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2022|
Heart failure patients where the etiology of their heart failure has been diagnosed. This cohort will consist of 3 groups: 1) Ischemic cardiomyopathy, 2) dilated cardiomyopathy and 3) diastolic heart failure
This cohort will consist of symptomatic heart failure patients diagnosed within 2 years.
Age matched healthy volunteers for comparison with heart failure patients
- Accuracy of heart failure panel to predict etiology of heart failure using biomarkers. [ Time Frame: at end of study ]
- cost savings [ Time Frame: At end of study ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347722
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Peter Liu, MSc, MD||Ottawa Heart Institute Research Corporation|