ReDS-Guided Therapy for Heart Failure

(RADAR-HF Trial)

Overseen By Cynthia Partida-Higuera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Intravenous diuretics, IV vasoactive

Disqualifiers: Chronic renal failure, Cardiogenic shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing heart failure in hospitalized patients. A special vest measures lung fluid levels, aiding doctors in determining the best treatment to remove excess fluid. Participants will receive either standard care or treatment guided by the vest's readings (ReDS-Guided Therapy). The trial seeks patients hospitalized for heart failure who require specific IV medications. As an unphased trial, it offers patients the chance to contribute to innovative heart failure management techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ReDS-Guided therapy is safe for heart failure patients?

Research has shown that the ReDS system, a wearable vest that measures lung fluid, is safe to use. Studies indicate that this technology helps manage fluid levels in people with heart failure. It has been used in both hospitals and homes without major safety issues. Prospective trial participants can feel confident knowing it has been tested and is well-tolerated by previous patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ReDS-Guided Therapy for heart failure because it offers a personalized approach to managing fluid levels in the lungs. Unlike standard care, which relies on general clinical assessments, this method uses a ReDS vest to precisely measure lung fluid and guide treatment decisions. The ability to tailor diuresis based on real-time lung fluid data could lead to more effective and timely management of heart failure, potentially reducing hospital stays and improving patient outcomes.

What evidence suggests that the ReDS-Guided therapy is effective for heart failure?

Research shows that ReDS technology, which involves wearing a vest to check lung fluid levels, can help manage heart failure. In this trial, clinicians will use lung fluid measurements from participants in the ReDS-Guided arm to guide treatment. Studies indicate that patients using ReDS are much less likely to return to the hospital than those who don't use it. Specifically, one study found that the chance of readmission dropped by 60% for patients using ReDS. This suggests that ReDS can help keep patients out of the hospital by providing doctors with better information about lung fluid levels. This early evidence indicates that ReDS could be a promising tool for effectively managing heart failure. ^{2 3 6 7 8}

Who Is on the Research Team?

Liviu Klein, MD, MS

Principal Investigator

Director, Mechanical Circulatory Support and Heart Failure Device Program

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My kidney function is good.

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

Your ReDS measurement is higher than 35%.

Exclusion Criteria

You are not eligible if you are shorter than 155cm or taller than 190cm, have a BMI less than 22 or greater than 39, have a chest circumference less than 80cm or greater than 115cm, or have a flail chest.

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

I had heart surgery less than 2 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive daily ReDS measurements to guide diuresis during hospitalization

7 days

Daily in-hospital monitoring

Follow-up

Participants are monitored for major adverse cardiac events and heart failure readmission

30 days

What Are the Treatments Tested in This Trial?

Interventions

• ReDS-Guided
• Usual Care

Trial Overview

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.

How Is the Trial Designed?

Group I: ReDS-Guided Experimental Treatment 1 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: Control Placebo Group 1 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

ReDS-Guided is already approved in United States, European Union for the following indications:

Approved in United States as ReDS Technology for:

• Monitoring lung fluid content in hospitalized patients with heart failure

Approved in European Union as ReDS System for:

• Assessment of lung fluid content in acute decompensated heart failure

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Sensible Medical Innovations Ltd.

Industry Sponsor

Trials

2

Recruited

480+

Published Research Related to This Trial

Remote dielectric sensing (ReDS) is a promising non-invasive technology for quantifying pulmonary edema in patients with heart failure, showing a strong correlation with lung fluid content.

However, in patients with comorbidities like chronic obstructive pulmonary disease (COPD), ReDS values may be inaccurately low due to the attenuation of electromagnetic waves, highlighting the need for caution in interpreting results in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with remote dielectric sensing (ReDS) for acute decompensated heart failure complicated by chronic obstructive pulmonary disease. Izumida, T., Imamura, T., Tanaka, S., et al.[2022]

Heart failure remains a significant health issue worldwide, with patients experiencing reduced quality of life and high rates of morbidity and mortality despite existing treatments for reduced left ventricular ejection fraction (LVEF).

Remote monitoring technologies, including wearable devices and patient self-managed testing, show promise in improving care delivery and clinical outcomes for heart failure patients, regardless of their LVEF status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A current and future outlook on upcoming technologies in remote monitoring of patients with heart failure. Bekfani, T., Fudim, M., Cleland, JGF., et al.[2021]

The Remote Dielectric Sensing (ReDS) device demonstrated almost perfect intra-rater reliability (ICC values of 0.966 and 0.988), indicating that a single trained examiner can consistently measure lung fluid levels without needing to repeat measurements.

Inter-rater reliability was substantial (ICC values of 0.683 and 0.866), suggesting that while multiple examiners can use the ReDS device effectively, having measurements taken by different examiners may lead to some variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Inter-Rater and Intra-Rater Reliability of Remote Dielectric Sensing Measurement. Hori, M., Imamura, T., Fukuo, A., et al.[2022]

Remote monitoring of hemodynamic parameters in heart failure patients has shown initial success in improving clinical outcomes, suggesting it may be a valuable tool in managing the condition.

In contrast, using daily weight monitoring alone has not demonstrated broad benefits in larger studies, indicating that more complex, multi-parameter approaches may be necessary for effective heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Physiologic Monitoring for Heart Failure. Ali, O., Hajduczok, AG., Boehmer, JP.[2022]

In a study of 436 hospitalized patients with cardiovascular diseases, remote dielectric sensing (ReDS) technology was used to measure pulmonary congestion, revealing that underweight patients had significantly lower indexed ReDS values compared to normal weight, pre-obese, and obese patients.

The findings suggest that ReDS values may be underestimated in underweight individuals, indicating that healthcare providers should exercise caution when interpreting ReDS results in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Remote Dielectric Sensing and Body Mass Index. Izumida, T., Imamura, T., Nakagaito, M., et al.[2023]

In a study of 25 patients with severe aortic stenosis, there was a moderate inverse correlation between the six-minute walk distance (6MWD) and remote dielectric sensing (ReDS) values, suggesting that shorter walking distances are associated with higher levels of pulmonary congestion.

The ReDS system effectively distinguished patients with mild or greater pulmonary congestion (ReDS value ≥30%) at a 6MWD cut-off of 170 meters, indicating its potential utility in assessing lung fluid levels in patients undergoing trans-catheter aortic valve replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of remote dielectric sensing and six-minute walk distance among those with severe aortic stenosis. Imamura, T., Narang, N., Izumida, T., et al.[2023]

Remote monitoring (RM) devices can help identify early signs of heart failure decompensation, potentially reducing the overall burden of heart failure, which is a major health issue worldwide.

The paper provides a comprehensive review of RM devices and clinical trials, emphasizing practical implementation strategies for these technologies in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure Remote Monitoring: A Review and Implementation How-To. Kobe, EA., McVeigh, T., Hameed, I., et al.[2023]

Remote dielectric sensing (ReDS™) is a promising noninvasive technology that can effectively measure lung fluid levels in patients with chronic heart failure, showing a moderate correlation with invasive pulmonary capillary wedge pressure measurements (r = 0.698).

In patients with a body height of less than 155 cm, ReDS values can still accurately predict elevated pulmonary capillary wedge pressure, indicating its potential utility in estimating cardiac pressure regardless of body size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Lung Fluid Levels Estimated by Remote Dielectric Sensing Values and Invasive Hemodynamic Measurements. Imamura, T., Hori, M., Ueno, Y., et al.[2023]

Remote dielectric sensing (ReDS) is a promising non-invasive technology that can quickly measure lung fluid levels in patients with chronic heart failure, potentially aiding in the management of pulmonary congestion.

With its high negative predictive value, ReDS may be particularly useful for ruling out cardiac causes of shortness of breath in outpatient settings, although further research is needed to confirm its effectiveness in guiding treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implications of remote dielectric sensing system to estimate lung fluid levels. Imamura, T., Narang, N., Kinugawa, K.[2023]

Remote dielectric sensing (ReDS) monitoring significantly reduces the odds of hospital readmission for heart failure patients, with an odds ratio of 0.40 based on a meta-analysis of 985 patients across seven studies.

The effectiveness of ReDS in lowering readmission rates is consistent within 30 days and up to 3 months, indicating its potential as a valuable tool for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of remote dielectric sensing (ReDS) in the prevention of heart failure rehospitalizations: a meta-analysis. Sattar, Y., Zghouzi, M., Suleiman, AM., et al.[2021]

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A ReDS-guided strategy to treat congestion improved 1-month prognosis postdischarge in this proof-of-concept study, mainly because of a decrease of the number ...

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