- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052804
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics (Alberta HEART)
May 2, 2022 updated by: Justin Ezekowitz, University of Alberta
The objectives of this study are: 1) to design new diagnostic criteria used to accurately define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular mechanisms involved with the development and progression of HFpEF; 4) to design and test new therapeutic strategies for patients with HFpEF.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2E1
- University of Alberta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Residents of Alberta, Canada with heart failure or at risk for developing heart failure
Description
Inclusion Criteria:
- Group 1 No clinically overt heart failure
- Group 2 Known coronary artery disease
- Group 3 Known heart failure with preserved ejection fraction
- Group 4 Known heart failure with reduced ejection fraction
- Group 5 Healthy age-matched controls
Exclusion Criteria:
- Age <18 years
- Known malignancy with expected survival <1 year
- Pregnant or recent pregnancy <6 months
- Recent event (<2 weeks since Acute Coronary Syndrome, Heart failure or other admission
- Severe mitral or aortic stenosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of patients meeting new diagnostic criteria for HFpEF
Time Frame: Up to 5 years
|
Up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jason Dyck, PhD, University of Alberta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zordoky BN, Sung MM, Ezekowitz J, Mandal R, Han B, Bjorndahl TC, Bouatra S, Anderson T, Oudit GY, Wishart DS, Dyck JR; Alberta HEART. Metabolomic fingerprint of heart failure with preserved ejection fraction. PLoS One. 2015 May 26;10(5):e0124844. doi: 10.1371/journal.pone.0124844. eCollection 2015.
- Ezekowitz JA, Becher H, Belenkie I, Clark AM, Duff HJ, Friedrich MG, Haykowsky MJ, Howlett JG, Kassiri Z, Kaul P, Kim DH, Knudtson ML, Light PE, Lopaschuk GD, McAlister FA, Noga ML, Oudit GY, Paterson DI, Quan H, Schulz R, Thompson RB, Weeks SG, Anderson TJ, Dyck JR. The Alberta Heart Failure Etiology and Analysis Research Team (HEART) study. BMC Cardiovasc Disord. 2014 Jul 25;14:91. doi: 10.1186/1471-2261-14-91.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2009
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
May 2, 2022
Study Registration Dates
First Submitted
January 21, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
May 2, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHFMRITG200801018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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