← Back to Search

Remote Dielectric Sensing

ReDS-Guided Therapy for Heart Failure (RADAR-HF Trial)

N/A

Recruiting

Led By Liviu Klein, MD, MS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

GFR>25

Patients hospitalized for acute decompensated heart failure requiring treatment with intravenous diuretics and/or IV vasoactive drugs

Must not have

Evidence of focal lung lesions on history, physical exam or chest x-ray, including history of pulmonary embolism, active pneumonia, or known lung nodule

Prior cardiac surgery within 2 months of index admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after discharge

Summary

This trialtests a vest that can measure lung fluid without surgery in people with heart failure in hospital.

Who is the study for?

This trial is for adults hospitalized with acute decompensated heart failure who need IV diuretics or vasoactive drugs. They must be able to wear a ReDS vest (certain body size restrictions apply), have a GFR over 25, and an initial lung fluid measurement above 35%. Exclusions include severe conditions like cardiogenic shock, certain heart malformations, recent cardiac surgery, chronic renal failure, or having a ventricular assist device.

What is being tested?

The study tests if monitoring lung fluid using a wearable vest called ReDS can guide the treatment of patients with acute decompensated heart failure better than usual care without this technology. The goal is to see if this non-invasive method improves patient outcomes during hospitalization.

What are the potential side effects?

Since the intervention involves wearing a non-invasive vest and does not involve medication changes beyond standard care for heart failure, side effects are minimal but may include discomfort from wearing the vest.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney function is good.

Select...

I am in the hospital for worsening heart failure needing IV medications.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I have had lung issues like clots, pneumonia, or nodules found.

Select...

I had heart surgery less than 2 months ago.

Select...

I needed medicine to support my heart's pumping action when I was admitted.

Select...

I have a heart defect or mass in my chest that affects my right lung's structure.

Select...

My kidney function is very low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after discharge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Net Fluid Balance during hospitalization

Secondary study objectives

Change in GFR from admission to discharge

Length of Stay in hospital

Major adverse cardiac events at 30 days

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ReDS-GuidedExperimental Treatment1 Intervention

Patients in the intervention arm will undergo daily measurements of lung fluid content at the bedside with the ReDS vest. The values will be shared with the treating clinicians, who can use the measurements in addition to other standard data to guide diuresis. Patients should be discharged only once their lung fluid content falls within the normal range of 20-35%.

Group II: ControlPlacebo Group1 Intervention

Patients in the control arm will also undergo daily measurements of lung fluid content at the beside with the ReDS vest. However, the values will not be shared with the treating clinicians, who will direct management based on standard clinical tools

0 / 8Eligibility criteria met