NCT03103932 Biomarker Guided Discharge of Heart Failure Patients
| NCT ID | NCT03103932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Heart Failure; With Decompensation |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2017-08-26 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2017-08-26 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-centre, single blind, randomized study. Patients admitted to hospital with acute decompensated heart failure will be randomized to biomarker guided discharge algorithm vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours of admission. The NTproBNP results will be used to further stratify participants randomized to the biomarker guided group into lower and medium to higher risk pathways. Biomarkers will be repeated after 2-3 days and again prior to discharge. Specific care pathways will be followed for each of the lower risk and medium-higher risk groups. Biomarkers will be repeated 30 days post discharge. Participants will be followed with a phone call at 3 months and return for a follow up visit at 6 months post discharge for outcome evaluation.
Eligibility Criteria
Inclusion Criteria: * Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria Exclusion Criteria: * Patient unable to provide blood samples or cannot participate in follow-up * Patient with end stage organ failure * Kidney: creatinine \>350 μmol/L or Estimated GFR ≤15 ml/min * Liver dysfunction: liver function test \>2.5 times normal * Lungs: pulmonary FEV1\<50% predicted * Patient requiring intubation * Patient with an admission NTproBNP measurement of \>30,000 pg/ml * Patient listed for heart transplant, or admitted specifically for transplant workup * Patient in cardiogenic shock * Patient with life expectancy of less than 6 months, or has major co-morbidities such as new stroke, cancer, pneumonia, or other serious life threatening illness * Patient with conditions that will make it difficult to discharge from hospital such as a fall or waiting for a long term care bed * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may bias the result of the trial, or the patient's ability to participate in the trial * Patient who has participated in another research trial involving an investigational product in the past 30 days
Contact & Investigator
Peter Liu, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT03103932 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure; With Decompensation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03103932 currently recruiting?
Yes, NCT03103932 is actively recruiting participants. Contact the research team at emoga@ottawaheart.ca for enrollment information.
Where is the NCT03103932 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT03103932 clinical trial?
NCT03103932 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Peter Liu, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 750 participants.
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