Biomarkers to Classify Heart Failure

NCT02347722 | Active Not Recruiting

• 1 other identifier: 2014869-01H
• Study Type: observational
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate existing biomarkers and see if they can be used to accurately diagnose the etiology of heart failure.

Conditions

Heart Failure

Keywords

biomarkers; diagnosis; etiology of heart failure

Outcome Measures

Primary Outcomes (1)

• Accuracy of heart failure panel to predict etiology of heart failure using biomarkers.

  at end of study

Secondary Outcomes (1)

• cost savings

  At end of study

Study Arms (3)

Retrospective

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

Prospective

This cohort will consist of symptomatic heart failure patients diagnosed within 2 years.

Healthy volunteers

Age matched healthy volunteers for comparison with heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The retrospective cohort consists of stored blood samples from various biobanks. The prospective cohort consists of patients admitted to academic hospitals or outpatient clinics with symptomatic heart failure diagnosed within 2 years. The volunteer cohort consists of age matched healthy volunteers

You may qualify if:

• Patients admitted with symptomatic heart failure, diagnosed within 2 years.
• Diagnosis of congestive heart failure using the modified Framingham criteria:
• Simultaneous presence of at least 2 major criteria or 1 major criterion in conjunction with 2 minor criteria or a previous clear diagnosis of heart failure.
• Major criteria:
• Paroxysmal nocturnal dyspnea or orthopnea
• Neck vein distention
• Rales/Crackles (\>10 cm from base of lungs)
• Acute pulmonary edema
• S3 gallop
• Increased central venous pressure (\>16 cm H2O at right atrium)
• Hepatojugular reflux
• Weight loss \>4.5 kg in 5 days in response to treatment Echocardiographic left ventricular dysfunction
• Minor criteria:
• Bilateral ankle edema
• Nocturnal cough

You may not qualify if:

• Patients unable to provide blood sample
• Patients unable to provide consent
• Patient with life expectancy of less than 6 months, or has major co-morbidities.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational product in the past 30 days.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Genome Canada: collaborator
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma for biomarkers

MeSH Terms

Conditions

Heart Failure; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Liu, MSc, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: May 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)