ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

Remote Dielectric Sensing System: The ReDS system consists of 2 sensors that are placed (sitting or supine) on the front (infraclavicular) and back (below the scapula) of the patient's right hemithorax and in 45 seconds accurately quantifies the proportion of fluid in the lung. The sensors are connected via 1 cable to a touchscreen monitor that easily guides the measurement process and stores this information. The accuracy of this technology has been validated with high-resolution chest computed tomography and invasive hemodynamic measurements with a Swan-Ganz catheter. Normal ReDS values range between 20% and 35% (i.e., 20-35% of the lung would be fluid). Above 35% is considered congestive, whereas below 20% the lung would be "dry" or dehydrated.

Blinded ReDS data: The responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met.

Study summary

This clinical trial aims to determine whether a ReDS-guided treatment strategy is superior to the current standard of care for adults hospitalized with heart failure. Additionally, the study will evaluate the safety and cost-effectiveness of this approach.

The study seeks to answer the following key questions:

1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge?
2. What is the safety profile of this treatment strategy?

Researchers will compare the ReDS-based strategy against the current standard of care. All participants will:

* Undergo daily assessments using the ReDS device throughout their hospitalization.
* Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.

Eligibility

Primary outcome measure(s)

• Number of participants with an efficacy event at 1 month after discharge — From randomization to the end of follow-up at 1 month after hospitalization discharge
  The primary outcome measure is the combined event rate of all-cause mortality, HF readmission, and/or unexpected HF visits requiring diuretic adjustment at 1 month after discharge
• Number of participant with a safety event at 1 month after discharge — From randomization to the end of follow-up at 1 month after hospitalization discharge
  The primary outcome measure is the combined event rate of symptomatic systolic hypotension (\<90 mmHg), electrolyte imbalances (potassium below 3 or above 5.5 meq/L), and/or worsening of renal function compared to the baseline visit at the first post-discharge outpatient visit (at least 50% reduction in glomerular filtration rate).

Trial sites (25)

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