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Biomarker-Guided Discharge for Heart Failure (RADAR Trial)
N/A
Recruiting
Led By Peter Liu, MD
Research Sponsored by Peter Liu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment of first patient to completion of the study - expected to be about 2 years
Awards & highlights
RADAR Trial Summary
This trial is testing a new way of using biomarkers to help people with heart failure. Patients will be randomly assigned to either the new way or usual care. Biomarkers will be measured soon after admission to the hospital, and again before discharge. Outcomes will be measured at 3 and 6 months after discharge.
Who is the study for?
This trial is for hospital-admitted patients with acute decompensated heart failure who meet the modified Framingham criteria. Excluded are those unable to give blood samples, follow-up, or with end-stage organ failure, listed for a heart transplant, conditions complicating discharge, in another recent trial, severe lung issues requiring intubation, extremely high NTproBNP levels, in cardiogenic shock or with less than 6 months to live.Check my eligibility
What is being tested?
The study tests a biomarker guided discharge algorithm against usual care for heart failure patients. It's single-blind and randomizes participants in a 2:1 ratio. Biomarkers like NTproBNP are measured at admission and guide treatment pathways; they're checked again during hospital stay and after one month post-discharge.See study design
What are the potential side effects?
Since this trial focuses on using biomarkers to guide patient care rather than testing new medications directly, specific side effects aren't detailed here. However, any medical intervention carries potential risks which will be monitored throughout the study.
RADAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was hospitalized for worsening heart failure.
RADAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment of first patient to completion of the study - expected to be about 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment of first patient to completion of the study - expected to be about 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Secondary outcome measures
the total number of days alive and out of hospital during the first 6 months of follow up
Other outcome measures
Total cost savings for hospitalizations over the course of the study
RADAR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biomarker guided discharge pathwayExperimental Treatment1 Intervention
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.
Group II: Usual careActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Genome CanadaOTHER
14 Previous Clinical Trials
26,820 Total Patients Enrolled
1 Trials studying Heart Failure
511 Patients Enrolled for Heart Failure
Roche DiagnosticsIndustry Sponsor
54 Previous Clinical Trials
651,871 Total Patients Enrolled
9 Trials studying Heart Failure
13,095 Patients Enrolled for Heart Failure
Ottawa Heart Institute Research CorporationOTHER
188 Previous Clinical Trials
91,686 Total Patients Enrolled
18 Trials studying Heart Failure
10,394 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a tube to help me breathe.I was hospitalized for worsening heart failure.My organs are failing and cannot be recovered.I am on the heart transplant list or being evaluated for it.Your NTproBNP measurement at admission is higher than 30,000 pg/ml.I am currently experiencing a severe heart condition known as cardiogenic shock.I have conditions that may delay my hospital discharge, like a recent fall or waiting for a long-term care bed.My lung function is less than half of what is expected.I have a life expectancy of more than 6 months and no major new illnesses.My liver function tests are more than 2.5 times the normal range.My kidney function is severely impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Biomarker guided discharge pathway
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants in this clinical trial?
"The information on clinicaltrials.gov shows that this research is actively gathering participants, having been first posted in August 2017 and last updated June 2022."
Answered by AI
How many people can register for this experiment?
"Affirmative. Clinicaltrials.gov conveys that this medical research, which was initially announced on August 26th 2017, is currently searching for participants. 750 individuals are needed to be enlisted from one clinical facility."
Answered by AI
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