Recruiting

Observational Study

Sponsor:

Institute for Clinical Evaluative Sciences

Code:

NCT05028686

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

This study is a prospective registry that aims to predict readmissions in patients with heart failure, using -omics, machine learning, patient reported outcomes, clinical data and other high-dimensional data sources.

Conditions

Heart Failure

Study ID

NCT05028686

Start date

Feb 1, 2019

Status verified date

Aug, 2021

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any patient aged 18 years or older admitted to hospital or seen in the emergency department with heart failure defined clinically
  • The diagnosis will be guided by the Framingham criteria for HF and/or BNP. A BNP >400 will be defined as definite heart failure and BNP 100-400 classified as possible heart failure.
  • Provides informed consent

Exclusion Criteria:

  • Patients who cannot communicate due to dementia or severe cognitive deficits
  • non-Ontario residents
  • nursing home residents
  • those who are not discharged home but are discharged to a skilled nursing facility (long-term care or chronic institution)
  • those who are unable to communicate who do not have a proxy (e.g. spouse or close family member) to facilitate communication with the patient.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Hospitalized heart failure cohort

Patients hospitalized with heart failure

Interventions

No intervention

Observational cohort

Primary outcome measure

  • Cardiovascular readmission [ Time Frame: 30 day ]
  • Heart failure readmission [ Time Frame: 30 day ]

Central Contacts and Locations

Central contacts

Douglas S Lee, MD, PhD

4163403861dlee@ices.on.ca

Suzanne Perrett

4164804055suzanne.perrett@ices.on.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

Douglas Lee, MD, PhD

416-340-3861dlee@ices.on.ca

Desana Thayaparan, BSc

416-340-3721desana.thayaparan@uhn.ca

More Information

Sponsor

Institute for Clinical Evaluative Sciences

Last update posted

Sep 2, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institute for Clinical Evaluative Sciences on 2021-09-02.