Using a wearable vest to measure lung fluid in heart failure patients
Remote Dielectric Sensing Technology Guided Diuresis in Hospitalized Patients With Acute Decompensated Heart Failure
This study is testing a new wearable vest that measures lung fluid in heart failure patients to see if it can help them get better treatment compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03586336 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a wearable vest that non-invasively measures lung fluid content in hospitalized patients suffering from acute decompensated heart failure. The approach involves using Remote Dielectric Sensing (ReDS) technology to guide diuresis treatment, which is traditionally managed through less reliable clinical methods. Patients will be randomly assigned to either receive ReDS-guided treatment or usual care, with daily measurements taken for all participants. The goal is to determine if ReDS can improve patient outcomes by providing more accurate assessments of fluid status.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults with acute decompensated heart failure who require intravenous diuretics or vasoactive drugs.
Not a fit: Patients with chronic renal failure, significant lung issues, or those requiring inotropic support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management of fluid overload in heart failure patients, potentially reducing hospital stays and improving recovery times.
How similar studies have performed: Other studies utilizing non-invasive monitoring technologies have shown promise, suggesting that this approach could be beneficial, though the specific use of ReDS in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Liviu Klein, MD, MS — Director, Mechanical Circulatory Support and Heart Failure Device Program
- Study coordinator: Cynthia Partida-Higuera
- Email: Cynthia.Partida-Higuera@ucsf.edu
- Phone: 415-514-1125
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.