Actively Recruiting
Biomarker Candidates to Guide Discharge of Patients Hospitalized with Heart Failure
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-06
750
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ottawa Heart Institute Research Corporation
Lead Sponsor
G
Genome Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to discharge decision-making for patients hospitalized with acute decompensated heart failure. This randomized, single-blind study compares a biomarker-guided discharge algorithm using NTproBNP levels to usual care. The aim is to see if using NTproBNP and other biomarkers to guide treatment and discharge timing can improve patient outcomes. The study is conducted at multiple centers and sponsored by the Ottawa Heart Institute Research Corporation. Participants are randomly assigned in a 2:1 ratio to either usual care or the biomarker-guided discharge pathway. In the usual care group, treatment follows standard hospital practice without revealing NTproBNP results to care providers. In the biomarker-guided group, NTproBNP levels measured at admission stratify patients into lower risk (below 3,000 pg/ml) or medium-higher risk (3,000 pg/ml or above) pathways. Biomarkers are repeated on days 2-3 and before discharge to guide symptom management and discharge timing. The medium-higher risk group may receive extended treatment or telehealth monitoring if biomarker levels remain elevated. Throughout the study, participants complete quality of life questionnaires at admission and 30 days after discharge. Biomarkers are also measured 30 days post-discharge. Follow-up includes a phone call at 3 months and a clinic visit at 6 months to evaluate outcomes. The primary outcome is the total number of days alive and out of hospital during the first 30 days after heart failure diagnosis. Secondary outcomes include similar measurements over 6 months. This comprehensive follow-up helps assess the impact of biomarker-guided care on patient health and hospital use.
CONDITIONS
Brief Title
Biomarker Guided Discharge of Heart Failure Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
- Adults aged 18 years or older
You will not qualify if you...
- Unable to provide blood samples or participate in follow-up
- End stage organ failure including kidney (creatinine >350 µmol/L or estimated GFR ≤15 ml/min), liver dysfunction (liver function test >2.5 times normal), or lung disease (FEV1 <50% predicted)
- Requiring intubation
- Admission NTproBNP measurement >30,000 pg/ml
- Listed for heart transplant or admitted for transplant workup
- Cardiogenic shock
- Life expectancy less than 6 months or major comorbidities such as new stroke, cancer, pneumonia, or other serious illness
- Conditions making discharge difficult such as recent fall or waiting for long term care bed
- Any other significant disease or disorder that may put the patient at risk or bias study results
- Participation in another investigational product trial in the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration varies based on biomarker response and clinical stabilization, typically up to 1 week.
Participants hospitalized with heart failure will be treated according to either usual care or a biomarker guided discharge algorithm based on NTproBNP levels, with repeated biomarker measurements to guide discharge timing.
Biomarker measurements on Day 2-3 and prior to discharge; daily monitoring for some participants discharged on telehealth
Duration - 30 days post discharge
Participants complete a Quality of Life questionnaire at 30 days post discharge to assess recovery and wellbeing.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
E
Ermina Moga, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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