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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

Must not have

Patient requiring intubation

Patient with end stage organ failure

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for worsening heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need a tube to help me breathe.

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My organs are failing and cannot be recovered.

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I am on the heart transplant list or being evaluated for it.

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I am currently experiencing a severe heart condition known as cardiogenic shock.

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My lung function is less than half of what is expected.

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I have a life expectancy of more than 6 months and no major new illnesses.

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My liver function tests are more than 2.5 times the normal range.

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My kidney function is severely impaired.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment of first patient to completion of the study - expected to be about 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis

Secondary study objectives

the total number of days alive and out of hospital during the first 6 months of follow up

Other study objectives

Total cost savings for hospitalizations over the course of the study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met