NCT05028686

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress68%
Feb 2019Sep 2029

Study Start

First participant enrolled

February 1, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Expected
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

5.7 years

First QC Date

August 25, 2021

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular readmission

    Non-elective readmission to hospital for a cardiovascular cause

    30 day

  • Heart failure readmission

    Non-elective readmission to hospital for heart failure

    30 day

Secondary Outcomes (3)

  • Mortality

    30-day

  • Cardiovascular death

    30-day

  • All-cause readmission

    30-day

Study Arms (1)

Hospitalized heart failure cohort

Patients hospitalized with heart failure

Other: No intervention

Interventions

Observational cohort

Hospitalized heart failure cohort

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized heart failure patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are stored in a biobank

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Douglas S Lee, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

February 1, 2019

Primary Completion

September 30, 2024

Study Completion (Estimated)

September 30, 2029

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations