Heart FailureAlberta HEARTNCT02052804
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics
An observational study of Heart Failure, run by University of Alberta at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 700 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2009to 2 May 2022
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Alberta, Canada with heart failure or at risk for developing heart failure
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta, T6G 2E1
About this study
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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients meeting new diagnostic criteria for HFpEF
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startApr 2009
- Primary completionDec 2015
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Ezekowitz, University of Alberta
- Investigators
- Jason Dyck, PhD, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052804
- Sponsor's protocol ID
- AHFMRITG200801018
- Acronym
- Alberta HEART
- Status last verified
- May 2022
- First submitted
- 21 Jan 2014
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26010610Ezekowitz 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.
PubMed 25063541
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics
- ClinicalTrials.gov ID
- NCT02052804
- Acronym / sponsor ID
- Alberta HEART / AHFMRITG200801018
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 3 Feb 2014 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Alberta, Canada with heart failure or at risk for developing heart failure
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
Percent of patients meeting new diagnostic criteria for HFpEF
Time frame: Up to 5 years
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 3 May 2022.
- Derived from this study: PubMed 26010610Zordoky 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.
- Derived from this study: PubMed 25063541Ezekowitz 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.
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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.
Jason Dyck, PhD study director
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Alberta at 2 sites in Canada.
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 5 inclusion and 5 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Percent of patients meeting new diagnostic criteria for HFpEF (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052804, which also lists 2 linked publications.
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 3 May 2022.