Testing Biomarker guided discharge algorithm for heart failure
Official title: Biomarker Guided Discharge of Heart Failure Patients
BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
Interventions
Biomarker guided discharge algorithm
participants randomized to the biomarker guided discharge algorithm will follow a pre-determined care pathway for treatment of heart failure symptoms based on admission NTproBNP levels
Canadian Sites (1)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
Exclusion
- −Patient unable to provide blood samples or cannot participate in follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: BiomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → guided discharge algorithm.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 750 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to 30 days post randomization.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis — measured over RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to 30 days post randomization.
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis — measured over Randomization to 30 days post randomization.
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis — measured over Randomization to 30 days post randomization.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03103932 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Biomarker guided discharge algorithmOther
participants randomized to the biomarker guided discharge algorithm will follow a pre-determined care pathway for treatment of heart failure symptoms based on admission NTproBNP levels
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to 30 days post randomization.
The study as a whole is currently expected to finish around 2026-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 750 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.