ReDS-guided strategy for 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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 7 days for reporting.

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 more

Awards & 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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