Understanding and Treating Heart Failure With Preserved E... | NCT02052804

Studies
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics

NCT02052804

Sponsor

University of Alberta

Status

Completed

Last Update Posted

May 3, 2022Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009Actual

Primary Completion Date

Dec 2015Actual

Completion Date

May 2, 2022Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 30, 2014

First Posted Date

Feb 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2022

Last Update Posted Date

May 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Justin Ezekowitz, Associate Professor, University of Alberta; Director, Heart Function Clinic- Mazankowski Alberta Heart Institute, University of AlbertaPrincipal Investigator

Lead Sponsor

University of AlbertaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of patients meeting new diagnostic criteria for HFpEF		Up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Dyck, PhD	University of Alberta	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary		Calgary	Alberta	T2N 4N1	Canada
University of Alberta

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26010610	Derived	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.
25063541	Derived

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases