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Remote Dielectric Sensing
ReDS-Guided Therapy for Heart Failure (RADAR-HF Trial)
N/A
Recruiting
Led By Liviu Klein, MD, MS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
GFR>25
Patients hospitalized for acute decompensated heart failure requiring treatment with intravenous diuretics and/or IV vasoactive drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after discharge
Awards & highlights
RADAR-HF Trial Summary
This trialtests a vest that can measure lung fluid without surgery in people with heart failure in hospital.
Who is the study for?
This trial is for adults hospitalized with acute decompensated heart failure who need IV diuretics or vasoactive drugs. They must be able to wear a ReDS vest (certain body size restrictions apply), have a GFR over 25, and an initial lung fluid measurement above 35%. Exclusions include severe conditions like cardiogenic shock, certain heart malformations, recent cardiac surgery, chronic renal failure, or having a ventricular assist device.Check my eligibility
What is being tested?
The study tests if monitoring lung fluid using a wearable vest called ReDS can guide the treatment of patients with acute decompensated heart failure better than usual care without this technology. The goal is to see if this non-invasive method improves patient outcomes during hospitalization.See study design
What are the potential side effects?
Since the intervention involves wearing a non-invasive vest and does not involve medication changes beyond standard care for heart failure, side effects are minimal but may include discomfort from wearing the vest.
RADAR-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good.
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I am in the hospital for worsening heart failure needing IV medications.
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I am 18 years old or older.
RADAR-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Net Fluid Balance during hospitalization
Secondary outcome measures
Change in GFR from admission to discharge
Length of Stay in hospital
Major adverse cardiac events at 30 days
RADAR-HF Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ReDS-GuidedExperimental Treatment1 Intervention
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%.
Group II: ControlPlacebo Group1 Intervention
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
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,455 Total Patients Enrolled
23 Trials studying Heart Failure
54,466 Patients Enrolled for Heart Failure
Sensible Medical Innovations Ltd.Industry Sponsor
1 Previous Clinical Trials
380 Total Patients Enrolled
1 Trials studying Heart Failure
380 Patients Enrolled for Heart Failure
Liviu Klein, MD, MSPrincipal InvestigatorDirector, Mechanical Circulatory Support and Heart Failure Device Program
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not eligible if you are shorter than 155cm or taller than 190cm, have a BMI less than 22 or greater than 39, have a chest circumference less than 80cm or greater than 115cm, or have a flail chest.I have had lung issues like clots, pneumonia, or nodules found.I had heart surgery less than 2 months ago.I needed medicine to support my heart's pumping action when I was admitted.I have a heart defect or mass in my chest that affects my right lung's structure.My kidney function is good.I am in the hospital for worsening heart failure needing IV medications.Your ReDS measurement is higher than 35%.I am 18 years old or older.You have a heart pump or have had a heart transplant.My kidney function is very low.The patient is physically able to have their ReDS (lung fluid status) measured.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: ReDS-Guided
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available for participants of this experiment?
"According to the official clinicaltrials.gov website, this medical experiment is presently recruiting study participants. It was initially uploaded on December 1st 2018 and has been most recently modified on November 28th 2022."
Answered by AI
How many volunteers are engaged in this experiment?
"Affirmative, the records on clinicaltrials.gov indicate that this study is still in search of participants. It was initially published on December 1st 2018 and last updated on November 28th 2022. There needs to be a total of 100 patients recruited from one medical site."
Answered by AI
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