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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure

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 data supports the effectiveness of the ReDS-Guided treatment for heart failure?

Research shows that using ReDS technology to monitor heart failure patients significantly reduces the chances of hospital readmission within three months compared to those not using ReDS. ^{1 2 3 4 5}

Is ReDS-Guided Therapy safe for humans?

The available research on ReDS technology, which is used to measure lung fluid levels, does not report any safety concerns in humans. It has been tested in both patients with heart conditions and healthy volunteers without any reported adverse effects. ^{1 6 7 8 9}

What makes ReDS-Guided Therapy unique for heart failure treatment?

ReDS-Guided Therapy is unique because it uses a non-invasive technology to measure lung fluid levels quickly, helping to manage heart failure by reducing hospital readmissions. This electromagnetic-based system provides real-time data on pulmonary congestion, which is not available with standard care methods. ^{1 3 6 8 10}

Research Team

Liviu Klein, MD, MS

Principal Investigator

Director, Mechanical Circulatory Support and Heart Failure Device Program

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of remote dielectric sensing (ReDS) in the prevention of heart failure rehospitalizations: a meta-analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A current and future outlook on upcoming technologies in remote monitoring of patients with heart failure. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical implications of remote dielectric sensing system to estimate lung fluid levels. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Remote Physiologic Monitoring for Heart Failure. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Heart Failure Remote Monitoring: A Review and Implementation How-To. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Association between Lung Fluid Levels Estimated by Remote Dielectric Sensing Values and Invasive Hemodynamic Measurements. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Association of remote dielectric sensing and six-minute walk distance among those with severe aortic stenosis. [2023]

8. Japan pubmed.ncbi.nlm.nih.gov

Association Between Remote Dielectric Sensing and Body Mass Index. [2023]

9. Japan pubmed.ncbi.nlm.nih.gov

Validation of Inter-Rater and Intra-Rater Reliability of Remote Dielectric Sensing Measurement. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

Experience with remote dielectric sensing (ReDS) for acute decompensated heart failure complicated by chronic obstructive pulmonary disease. [2022]