NCT04009798

Brief Summary

The purpose of the project is to conduct a physician-initiated Canadian multicentre observational research study that compares physician judgement and model prediction to estimate one-year survival in ambulatory heart failure (HF) patients and evaluate the use of resources according to physician intuitive risk. This study will evaluate the accuracy and impact of physician intuition and predictive models in the assessment of prognosis in ambulatory HF patients by: comparing 1-year physician predicted survival and 1-year observed survival to 1-year model predicted survival; evaluating whether model performance could be enhanced by incorporating physician intuition; evaluating the accuracy of physician intuition according to level of confidence in physician intuition (very low, low, moderate, high or very high); evaluating whether physician expertise impacts accuracy of physician intuition; and evaluating patient management and use of resources according to physician estimated survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 18, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 30, 2021

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

July 3, 2019

Last Update Submit

April 29, 2021

Conditions

Heart Failure

Keywords

heart failurerisk predictionprognosis

Outcome Measures

Primary Outcomes (3)

  • Mortality

    All-cause mortality

    1-year

  • Heart Transplant

    Heart transplant within 1 year of study enrolment

    1-year

  • Left Ventricular Assist Device

    Left ventricular assist device implant within 1 year of study enrolment

    1-year

Secondary Outcomes (2)

  • Heart Failure Hospitalization

    1-year

  • Utilization of health resources and related costs

    1-year

Eligibility Criteria

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

Consecutive ambulatory adult heart failure patients with a reduced ejection fraction ≤40%.

You may qualify if:

  • Ambulatory HF patients followed in a HF clinic
  • Adults (\>18 years)
  • Have a left ventricular ejection fraction (LVEF) ≤40% by echocardiogram

You may not qualify if:

  • HF patients with preserved LVEF (\>40%)
  • HF patients already on ventricular assist device support
  • Patients with acutely decompensated HF at the time of the clinic visit requiring admission or with a HF admission in the previous month to the index clinic visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (3)

  • Alba AC, Buchan TA, Mueller B, Poon S, Mak S, Al-Hesayen A, Toma M, Zieroth S, Anderson K, Demers C, Faizan A, Porepa L, Chih S, Giannetti N, Rac V, Ross HJ, Guyatt GH. Predictive Models Aid Prognostication: Secondary Analysis Integrating Model and Physician Prognostic Estimates in Heart Failure. JACC Adv. 2025 Nov;4(11 Pt 1):102281. doi: 10.1016/j.jacadv.2025.102281. Epub 2025 Oct 24.

    PMID: 41135380DERIVED

  • Alba AC, Buchan TA, Saha S, Fan S, Poon S, Mak S, Al-Hesayen A, Toma M, Zieroth S, Anderson K, Demers C, Amin F, Porepa L, Chih S, Giannetti N, Rac V, Ross HJ, Guyatt GH. Factors Impacting Physician Prognostic Accuracy in Heart Failure Patients With Reduced Left Ventricular Ejection Fraction. JACC Heart Fail. 2024 May;12(5):878-889. doi: 10.1016/j.jchf.2024.02.009. Epub 2024 Mar 27.

    PMID: 38551522DERIVED

  • Alba AC, Buchan TA, Saha S, Fan S, Demers C, Poon S, Mak S, Al-Hesayen A, Toma M, Zieroth S, Anderson K, Porepa L, Chih S, Giannetti N, Rac V, Levy WC, Ross HJ, Guyatt GH. Predicting 1-Year Mortality in Outpatients With Heart Failure With Reduced Left Ventricular Ejection Fraction: Do Empiric Models Outperform Physician Intuitive Estimates? A Multicenter Cohort Study. Circ Heart Fail. 2023 Jul;16(7):e010312. doi: 10.1161/CIRCHEARTFAILURE.122.010312. Epub 2023 Jun 20.

    PMID: 37337896DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ana C Alba, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 5, 2019

Study Start

May 18, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 30, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)