Status:
RECRUITING
Use of ReDS Technology in Patients With Acute Heart Failure
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Heart Failure
Lung Congestion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 dielectr...
Detailed Description
Heart failure (HF) is an increasing epidemic and a major public health priority, affecting more than 6 million patients in the United States of America (1). Specially, acutely decompensated HF (ADHF) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04305717
Start Date
August 14 2020
End Date
December 1 2021
Last Update
February 21 2021
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029