- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03103932
Biomarker Guided Discharge of Heart Failure Patients (RADAR)
BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Care Pathways:
Usual care: Participants will be treated for their heart failure symptoms as is usual at each participating institution. NTproBNP results will not be revealed to the care providers.
NTproBNP levels of participants randomized to the biomarker guided discharge algorithm will be posted on the participant's medical records. The results will be used by the care providers for decision making according to the predetermined care pathway.
Lower risk group: Participants who's admission NTproBNP is below 3,000 pg/ml will be placed into the lower risk group. Discharge planning will start within 24 hours of hospital admission. Symptoms will be treated aggressively. If the NTproBNP level drops to 1,500 pg/ml or below on Day 2-3, the participant will be discharged home. If the NTproBNP level does not drop to below 1,500 pg/ml, the participant will continue on treatment for another day or two and be discharged home when medically stabilized.
Medium-higher risk group: Participants who's admission NTproBNP is 3,000 pg/ml or above will be placed into the medium-higher risk group. Symptoms will be treated aggressively. If the NTproBNP level drops to below 3,000 pg/ml on Day 2-3, the participant will follow the lower risk pathway until discharge. If the NTproBNP level remains above 3,000 pg/ml, aggressive treatment of symptoms will continue. Biomarkers will be repeated on Day 6-7. If the NTproBNP level has dropped by at least 30% from admission and the participant is medically stabilized, the participant will be discharged home. If the NTproBNP level has not dropped by at least 30% from admission, treatment will continue until the participant is medically stabilized. This last group will be discharged home on telehealth with daily monitoring.
All participants will complete a Quality of Life questionnaire at admission and at the 30 day post discharge follow up.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ermina Moga, MD
- Phone Number: 10945 613-696-7000
- Email: emoga@ottawaheart.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- Recruiting
- University of Ottawa Heart Institute
-
Contact:
- Ermina Moga, MD
- Phone Number: 10945 613-696-7000
- Email: emoga@ottawaheart.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
Participants will be treated as is usual at each institution.
Biomarkers will be measured on Day 2-3 and again prior to discharge from hospital.
NTproBNP levels will not be revealed to care providers.
|
|
Experimental: Biomarker guided discharge pathway
Admission NTproBNP levels will be used to stratify participants into lower and medium-higher risk care pathways.
NTproBNP levels will be repeated on Day 2-3 and again prior to discharge.
Each care pathway is designed to optimize discharge time according to NTproBNP levels.
All NTproBNP results will be displayed on the front of the participant's chart along with the care pathway that the participant has been randomized to.
The care providers will be reminded daily by the study team that the participant is in the biomarker guided discharge pathway arm of the study and that the designated care pathway should be followed as closely as possible.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Time Frame: Randomization to 30 days post randomization
|
The investigator will measure te total number of days in hospital for each group
|
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
Time Frame: Randomization to 30 days post randomization
|
The investigator will measure the number of rehospitalizations in each group
|
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
Time Frame: Randomization to 30 days post randomization
|
The investigator will measure the total number of deaths and hospitalization episodes in each group
|
Randomization to 30 days post randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the total number of days alive and out of hospital during the first 6 months of follow up
Time Frame: Randomization to 6 months post randomization
|
The investigator will measure the total number of days in hospital in each group
|
Randomization to 6 months post randomization
|
the total number of days alive and out of hospital during the first 6 months of follow up
Time Frame: Randomization to 6 months post randomization
|
The investigator will measure The number of rehospitalizations in each group
|
Randomization to 6 months post randomization
|
the total number of days alive and out of hospital during the first 6 months of follow up
Time Frame: Randomization to 6 months post randomization
|
The investigator will measure the number of deaths/hospitalization episodes in each group
|
Randomization to 6 months post randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cost savings for hospitalizations over the course of the study
Time Frame: From enrollment of first patient to completion of the study - expected to be about 2 years
|
The investigator will measure the cost associated with each hospitalization in each group
|
From enrollment of first patient to completion of the study - expected to be about 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Liu, MD, Ottawa Heart Institute Research Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 806
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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