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Behavioural Intervention
Use of ReDS Technology in Patients With Acute Heart Failure
N/A
Recruiting
Led By Donna M Mancini
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 7 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a ReDS-guided strategy during heart failure admission is superior to the standard of care during a 1-month follow up, in terms of unplanned visits for heart failure, hospitalization for worsening heart failure, or death.
Eligible Conditions
- Congestive Heart Failure
- Heart Failure
- Lung Congestion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average of 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite outcome
Secondary study objectives
Breathlessness Visual Analog Scale
Change in Creatinine level
Change in NT-proBNP/BNP plasma levels
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ReDS-guided strategyExperimental Treatment1 Intervention
For patients in this arm, daily measurements from the device will be revealed to the treating physician. Discharge can be planned when the clinical stability is achieved and the ReDS value is ≤35%. In case of a ReDS value \>35%, treating physicians will follow a predefined algorithm before discharge to improve the results of ReDS test.
Group II: Standard of care strategyActive Control1 Intervention
The drugs dosage, especially diuretics, will be selected according to the presence of symptoms and signs of systemic congestion and according to current recommendations. All the daily ReDS measurements will be blinded to the treating physician.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
909 Previous Clinical Trials
541,903 Total Patients Enrolled
Donna M ManciniPrincipal InvestigatorIcahn School of Medicine