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Predicted Prognosis in Heart Failure (Intuition)

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ClinicalTrials.gov Identifier: NCT04009798
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease
Heart Failure

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physician Intuition Versus Model Predicted Prognosis in Heart Failure
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Mortality [ Time Frame: 1-year ]
    All-cause mortality

  2. Heart Transplant [ Time Frame: 1-year ]
    Heart transplant within 1 year of study enrolment

  3. Left Ventricular Assist Device [ Time Frame: 1-year ]
    Left ventricular assist device implant within 1 year of study enrolment


Secondary Outcome Measures :
  1. Heart Failure Hospitalization [ Time Frame: 1-year ]
    Heart failure related hospitalizations within 1 year of study enrolment

  2. Utilization of health resources and related costs [ Time Frame: 1-year ]
    Use and cost associated with health resource use within 1 year of study enrolment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Consecutive ambulatory adult heart failure patients with a reduced ejection fraction ≤40%.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009798


Contacts
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Contact: Ana C Alba, MD, PhD 416-340-4800 ext 8193 carolina.alba@uhn.ca
Contact: Tayler A Buchan, MSc 416-340-4800 ext 8193 tayler.buchan@uhnresearch.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Ana C Alba, MD, PhD    416-340-4800 ext 8193      
Contact: Tayler A Buchan, MSc    416-340-4800 ext 8193    tayler.buchan@uhnresearch.ca   
Principal Investigator: Ana C Alba, MD, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Ana C Alba, MD, PhD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04009798     History of Changes
Other Study ID Numbers: 17-6063
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
heart failure
risk prediction
prognosis
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases