Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
Recruiting · NCT03586336 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ReDS-GuidedUsual Care
What this trial is about
This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients hospitalized for acute decompensated heart failure requiring treatment with intravenous diuretics and/or IV vasoactive drugs
- Patient has signed informed consent and has authorized use and disclosed health information
- Patient is at least 18 years of age
- Patient physically suitable for ReDS measurement
- GFR\>25
- Initial ReDS Measurement \>35%
Exclusion criteria
- Patient characteristics excluded from approved use of ReDS system: height less than 155cm or greater than 190cm, BMI \<22 or \>39, chest circumference \<80cm or \>115cm , or flail chest
- Evidence of focal lung lesions on history, physical exam or chest x-ray, including history of pulmonary embolism, active pneumonia, or known lung nodule
- Chronic renal failure (GFR\<25)
- Prior cardiac surgery within 2 months of index admission
- Patient has a ventricular assist device or has had a cardiac transplantation
- Patients in cardiogenic shock at admission requiring inotropic support
- Congenital heart malformations or intra-thoracic mass that would affect right-lung anatomy (e.g dextrocardia, lung carcinoma, or pacemaker box in the right chest)
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States