Using ReDS technology to manage acute heart failure
Remote Dielectric Sensing (ReDS) for a SAFE Discharge in Patients With Acutely Decompensated Heart Failure: The ReDS-SAFE HF Study
This study is testing if a new technology called ReDS can help manage patients with acute heart failure in the hospital and reduce their chances of coming back after they leave.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04305717 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Remote Dielectric Sensing (ReDS) technology in managing patients with acute heart failure (HF) during their hospital admission. It aims to determine if a ReDS-guided strategy can reduce readmission rates compared to standard care over a one-month follow-up period. Approximately 240 hospitalized patients with acute decompensated HF will be randomly assigned to either the ReDS-guided management group or the standard care group. The study will assess changes in lung fluid concentration noninvasively to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently hospitalized for heart failure with signs of fluid overload.
Not a fit: Patients with certain exclusions, such as those on inotropes or with end-stage renal disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions for patients with acute heart failure.
How similar studies have performed: Previous non-randomized studies have suggested that ReDS-guided management may effectively reduce readmissions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Donna M Mancini — Icahn School of Medicine
- Study coordinator: Donna M Mancini
- Email: donna.mancini@mountsinai.org
- Phone: 212-241-7673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.