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Use of ReDS Technology in Patients With Acute Heart Failure

Remote Dielectric Sensing (ReDS) for a SAFE Discharge in Patients With Acutely Decompensated Heart Failure: The ReDS-SAFE HF Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Typically, fluid overload has been assessed through symptoms and signs, as well as other tools such as chest X-ray, plasma biomarkers, and echocardiography (6)."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether using ReDS, a device that measures fluid in the lungs without entering the body, helps guide care better than usual care. It is for adults in the hospital for worsening heart failure with fluid buildup. Researchers will track unplanned heart failure care, hospital stays, and deaths for 30 days after patients leave the hospital.

Background: Fluid overload, especially pulmonary congestion, is one of the main contributors into heart failure (HF) readmission risk and it is a clinical challenge for clinicians. The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively. Previous non-randomized studies suggest that ReDS-guided management has the potential to reduce readmissions in HF patients recently discharged from the hospital. Aims: To test whether a ReDS-guided strategy during HF admission is superior to the standard of care during a 1-month follow up. Methods: The ReDS-SAFE HF trial is an investigator-initiated, single center, single blind, 2-arm randomized clinical trial, in which \~240 inpatients with acutely decompensated HF at Mount Sinai Hospital will be randomized to a) standard of care strategy, with a discharge scheme based on current clinical practice, or b) ReDS-guided strategy, with a discharge scheme based on specific target value given by the device on top of the current clinical practice. ReDS tests will be performed for all study patients, but results will be blinded for treating physicians in the "standard of care" arm. The primary outcome will be a composite of unplanned visit for HF that lead to the use of intravenous diuretics, hospitalization for worsening HF, or death from any cause at 30 days after discharge. Secondary outcomes including the components of the primary outcome alone, length of stay, quality of life, time-averaged proportional change in the natriuretic peptides plasma levels, and safety events as symptomatic hypotension, diselectrolytemias or worsening of renal function. Conclusions: The ReDS-SAFE HF trial will help to clarify the efficacy of a ReDS-guided strategy during HF-admission to improve the short-term prognosis of patients after a HF admission.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You are in the hospital mainly for heart failure and have signs and symptoms of fluid buildup, no matter how well your heart pumps.
  • Your blood test shows NT-proBNP of at least 400 pg/L or BNP of at least 100 pg/L. These are markers linked to heart failure.

Who can't join

  • You are shorter than 155 cm or taller than 190 cm, or your body mass index (BMI, a measure based on height and weight) is below 22 or above 39.
  • You leave the hospital on inotropes (medicines that help the heart pump harder), have a heart pump device called an LVAD, or have had a heart transplant.
  • You have a heart defect present at birth or a mass inside your chest that affects the shape or position of your right lung.
  • You have end-stage kidney disease and receive hemodialysis, a treatment that filters your blood.
  • You are expected to live less than 12 months because of health problems other than heart disease.
  • You are in another study that assigns treatments by chance.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years old * Currently hospitalized for a primary diagnosis of HF, including symptoms and signs of fluid overload, regardless of left ventricular ejection fraction (LVEF), and a NT-proBNP concentration of ≥ 400 pg/L or a BNP concentration of ≥ 100 pg/L Exclusion Criteria: * Patient characteristics excluded from approved use of ReDS system: height \<155cm or \>190cm, BMI \<22 or \>39 * Patients discharged on inotropes, or with a left ventricular assist device or cardiac transplantation * Congenital heart malformations or intra-thoracic mass that would affect right-lung anatomy * End stage renal disease on hemodialysis * Life expectancy \<12 months due to non-cardiac comorbidities * Participating in another randomized study

Study sites (1)

NY