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Biomarker Guided Discharge of Heart Failure Patients (RADAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103932
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Genome Canada
Roche Diagnostics
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Peter Liu, Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE August 26, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 31, 2017)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Biomarker Guided Discharge of Heart Failure Patients
Official Title  ICMJE BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single blind, strategy based, randomized trial consisting of two main study arms
Masking: Double (Participant, Care 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.
Primary Purpose: Health Services Research
Condition  ICMJE Heart Failure; With Decompensation
Intervention  ICMJE Other: 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Biomarker guided discharge algorithm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Malaika Mohammed 613-696-7000 ext 10945 mmohammed@ottawaheart.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103932
Other Study ID Numbers  ICMJE 806
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be available to other researchers. Only results will be shared.
Responsible Party Peter Liu, Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Peter Liu
Collaborators  ICMJE
  • Genome Canada
  • Roche Diagnostics
  • Ottawa Heart Institute Research Corporation
Investigators  ICMJE
Principal Investigator: Peter Liu, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP