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NCT Number: NCT07484009

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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.

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Key information

Conditions

Acute Heart Failure (AHF) Cardiovascular Diseases Edema Heart Diseases Heart Failure Heart Failure (for Example, Fluid Overload) Heart Failure Hospitalization Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramón y Cajal University Hospital, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized due to heart failure as the main reason, including the presence of symptoms and signs of congestion, regardless of the left ventricular ejection fraction (LVEF).
  • NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission.

Exclusion criteria

  • Height less than 150 cm or greater than 190 cm or body mass index (BMI) less than 22 or greater than 39, conditions where the use of ReDS is not approved.
  • Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients.
  • Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
  • Patients with any heart disease requiring a planned surgical intervention (CABG, valve disease, or other) or percutaneous (TAVR, STE-ACS, mitral or tricuspid valve repair, CRT) during the clinical trial.
  • Chronic kidney disease with a GFR <20 or on hemodialysis.
  • Life expectancy less than 12 months due to non-cardiological origin.
  • Participation in another clinical trial with intervention.

Treatment and study plan

Remote dielectric sensing system

Device

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

Device

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.

Primary outcomes

  1. Number of participants with an efficacy event at 1 month after discharge

    Time frame: 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

  2. Number of participant with a safety event at 1 month after discharge

    Time frame: 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).

Secondary outcomes

  1. Cost-efficacy outcome measure

    Time frame: Length of stay of index admission

    Length of stay and cost of ReDS device

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Rey Iborra, BSN

CONTACT

[email protected]

Jesús Álvarez-García, MD, PhD

CONTACT

[email protected]

34 667495661

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Complejo Hospitalario Toledo
  • Complejo Hospitalario Universitario de Santiago
  • Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
  • Hospital Arnau de Vilanova
  • Hospital Clinic of Barcelona
  • Hospital Clínico Universitario de Valencia
  • Hospital General Universitario Gregorio Marañon
  • Hospital San Carlos, Madrid
  • Hospital Sant Joan Despí Moisès Broggi
  • Hospital Universitari de Bellvitge
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario La Paz
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Reina Sofia de Cordoba
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario Virgen de la Victoria
  • Hospital Vall d'Hebron
  • Hospital del Mar
  • Joan XXIII University Hospital
  • La Princesa University Hospital Madrid
  • Puerta de Hierro University Hospital
  • Salamanca University Hospital
  • University Hospital of Girona Dr. Josep Trueta

Registry information

Official study title

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial

Acronym: ReDS-SAFE HF 2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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