NCT02634762

Brief Summary

This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. The risk algorithms for prediction of 7-day (Emergency Heart failure Mortality Risk Grade \[EHMRG\]) and 30-day mortality (EHMRG30-ST) have been previously derived.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,983

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2011

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

6.9 years

First QC Date

December 16, 2015

Last Update Submit

March 28, 2018

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Death within 7 days after emergency department presentation for heart failure

    7 days

  • Mortality

    Death within 30 days after emergency department presentation for heart failure

    30 days

Eligibility Criteria

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

Patients presenting to the emergency department diagnosed with heart failure at 8 centers in Ontario, Canada

You may qualify if:

  • Patients with acute heart failure diagnosed in the emergency department

You may not qualify if:

  • Palliative or do-not-resuscitate (DNR) directive
  • Dialysis dependent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Lee DS, Lee JS, Schull MJ, Borgundvaag B, Edmonds ML, Ivankovic M, McLeod SL, Dreyer JF, Sabbah S, Levy PD, O'Neill T, Chong A, Stukel TA, Austin PC, Tu JV. Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure. Circulation. 2019 Feb 26;139(9):1146-1156. doi: 10.1161/CIRCULATIONAHA.118.035509.

    PMID: 30586748DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Douglas Lee, MD, PhD

    Institute for Clinical Evaluative Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

January 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

CA(1)