NCT02052804

Brief 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 progression of HFpEF; 4) to design and test new therapeutic strategies for patients with HFpEF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

6.7 years

First QC Date

January 21, 2014

Last Update Submit

May 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent of patients meeting new diagnostic criteria for HFpEF

    Up to 5 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Alberta, Canada with heart failure or at risk for developing heart failure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jason Dyck, PhD

    University of Alberta

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, University of Alberta; Director, Heart Function Clinic- Mazankowski Alberta Heart Institute

Study Record Dates

First Submitted

January 21, 2014

First Posted

February 3, 2014

Study Start

April 1, 2009

Primary Completion

December 1, 2015

Study Completion

May 2, 2022

Last Updated

May 3, 2022

Record last verified: 2022-05

Locations