Recruiting

ReDS

Sponsor:

UCLA

Code:

NCT03586336

Conditions

Heart Failure; With Decompensation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ReDS-Guided

Usual Care

Study Details

Brief summary:

This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure

Conditions

Heart Failure; With Decompensation

Study ID

NCT03586336

Start date

Dec 1, 2018

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ReDS-Guided

Patients in the intervention arm will undergo daily measurements of lung fluid content at the bedside with the ReDS vest. The values will be shared with the treating clinicians, who can use the measurements in addition to other standard data to guide diuresis. Patients should be discharged only once their lung fluid content falls within the normal range of 20-35%.

sham comparator: Control

Patients in the control arm will also undergo daily measurements of lung fluid content at the beside with the ReDS vest. However, the values will not be shared with the treating clinicians, who will direct management based on standard clinical tools

Interventions

ReDS-Guided

ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge

Usual Care

ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria

Primary outcome measure

  • Net Fluid Balance during hospitalization [ Time Frame: During hospitalization, approximately 7 days ]

Central Contacts and Locations

Central contacts

Cynthia Partida-Higuera

415-514-1125Cynthia.Partida-Higuera@ucsf.edu

Liviu Klein, MD, MS

415-476-2143liviu.klein@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Cassie Nguyen

415-353-9124cassie.nguyen@ucsf.edu

Liviu Klein, M.D.

415-476-2143liviu.klein@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-02.