Biomarker Guided Discharge of Heart Failure Patients (RADAR)

February 1, 2024 updated by: Peter Liu

BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Peter Liu, MD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2017

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be available to other researchers. Only results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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