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Biomarker Guided Discharge of Heart Failure Patients (RADAR)

Primary Purpose

Heart Failure; With Decompensation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Biomarker guided discharge algorithm
Sponsored by
Peter Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure; With Decompensation focused on measuring biomarkers, heart failure, hospital admission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Biomarker guided discharge pathway

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 28, 2017
Last Updated
January 13, 2023
Sponsor
Peter Liu
Collaborators
Genome Canada, Roche Diagnostics, Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03103932
Brief Title
Biomarker Guided Discharge of Heart Failure Patients
Acronym
RADAR
Official Title
BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Liu
Collaborators
Genome Canada, Roche Diagnostics, Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure; With Decompensation
Keywords
biomarkers, heart failure, hospital admission

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blind, strategy based, randomized trial consisting of two main study arms
Masking
ParticipantCare Provider
Masking Description
The assigned care pathway will not be revealed to the participant NTproBNP levels will not be revealed to care providers for the group randomized to usual care.
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Biomarker guided discharge pathway
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biomarker guided discharge algorithm
Intervention Description
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
Primary Outcome Measure Information:
Title
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Description
The investigator will measure te total number of days in hospital for each group
Time Frame
Randomization to 30 days post randomization
Title
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Description
The investigator will measure the number of rehospitalizations in each group
Time Frame
Randomization to 30 days post randomization
Title
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Description
The investigator will measure the total number of deaths and hospitalization episodes in each group
Time Frame
Randomization to 30 days post randomization
Secondary Outcome Measure Information:
Title
the total number of days alive and out of hospital during the first 6 months of follow up
Description
The investigator will measure the total number of days in hospital in each group
Time Frame
Randomization to 6 months post randomization
Title
the total number of days alive and out of hospital during the first 6 months of follow up
Description
The investigator will measure The number of rehospitalizations in each group
Time Frame
Randomization to 6 months post randomization
Title
the total number of days alive and out of hospital during the first 6 months of follow up
Description
The investigator will measure the number of deaths/hospitalization episodes in each group
Time Frame
Randomization to 6 months post randomization
Other Pre-specified Outcome Measures:
Title
Total cost savings for hospitalizations over the course of the study
Description
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 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ermina Moga, MD
Phone
613-696-7000
Ext
10945
Email
emoga@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Liu, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ermina Moga, MD
Phone
613-696-7000
Ext
10945
Email
emoga@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be available to other researchers. Only results will be shared.

Learn more about this trial

Biomarker Guided Discharge of Heart Failure Patients

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