Biomarker Guided Discharge of Heart Failure Patients
ConditionHeart Failure; With Decompensation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biomarker guided discharge algorithm
Other interventionparticipants 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
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Usual careNo intervention 0 interventions
Group B: Biomarker guided discharge pathwayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
The investigator will measure te total number of days in hospital for each group
Time frame
Randomization to 30 days post randomization2
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
The investigator will measure the number of rehospitalizations in each group
Time frame
Randomization to 30 days post randomization3
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
The investigator will measure the total number of deaths and hospitalization episodes in each group
Time frame
Randomization to 30 days post randomizationSecondary outcomes
1
the total number of days alive and out of hospital during the first 6 months of follow up
The investigator will measure the total number of days in hospital in each group
Time frame
Randomization to 6 months post randomization2
the total number of days alive and out of hospital during the first 6 months of follow up
The investigator will measure The number of rehospitalizations in each group
Time frame
Randomization to 6 months post randomization3
the total number of days alive and out of hospital during the first 6 months of follow up
The investigator will measure the number of deaths/hospitalization episodes in each group
Time frame
Randomization to 6 months post randomizationOther outcomes
1
Total cost savings for hospitalizations over the course of the study
The investigator will measure the cost associated with each hospitalization in each group
Time frame
From enrollment of first patient to completion of the study - expected to be about 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Heart Institute Research Corporation
Lead sponsor
Genome Canada
Collaborator
Roche Diagnostics GmbH
Collaborator
Source ClinicalTrials.gov