ReDS-guided decongestion for people hospitalized with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study compares a ReDS-guided decongestion strategy to usual care in adults admitted for acute heart failure with signs of congestion and elevated natriuretic peptides. Participants will have daily ReDS measurements during hospitalization and will be randomized to treatment guided by those measurements or to standard care with ReDS data blinded. Investigators will track cardiovascular events in the first 30 days after discharge, and will monitor safety and costs of the approach. Two follow-up visits are scheduled at about 2 weeks and 30 days after discharge to capture outcomes and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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).
2. NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission.

Exclusion Criteria:

1. 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.
2. Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients.
3. Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
4. 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.
5. Chronic kidney disease with a GFR \<20 or on hemodialysis.
6. Life expectancy less than 12 months due to non-cardiological origin.
7. Participation in another clinical trial with intervention.

Where it's running

• Ramón y Cajal University Hospital
  Madrid, Madrid, Spain Recruiting
• Bellvitge University Hospital
  Barcelona, Spain Recruiting
• Hospital del Mar
  Barcelona, Spain Recruiting
• Reina Sofía University Hospital
  Córdoba, Spain Recruiting
• Dr Josep Trueta University Hospital
  Girona, Spain Recruiting
• 12 de Octubre University Hospital
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Jesús Álvarez-García, MD, PhD — Ramón y Cajal University Hospital, Madrid, Spain
• Study coordinator: Jesús Álvarez-García, MD, PhD
• Email: jalvarezg82@gmail.com
• Phone: 34 667495661

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comprehensive clinical rule to diagnose acute heart failure in the emergency department

  A prospective study tests a combined clinical rule using patient data, a point-of-care NT-proBNP test, an 8-point lung ultrasound, and bedside echo to quickly diagnose acute heart failure in adults with new or worsening symptoms.

  Recruiting Chinese University of Hong Kong · Hong Kong and 2 other locations · NCT07754084

• Disrupted congestion in acute heart failure: can ultrasound at discharge predict readmission and death

  This study tests whether ultrasound checks of congestion at discharge can predict which patients with acute heart failure are more likely to be readmitted or die within 90 days.

  Recruiting University of Aarhus · Aarhus and 2 other locations · NCT07682298

• Non-Invasive Heart Failure Monitoring in Hospitalized Patients

  This study tests whether daily non-invasive thoracic measurements from the Acorai Device 1.0 can relate to health outcomes for adults hospitalized with heart failure.

  Recruiting Acorai AB · Lund · NCT07671742

• Pre-discharge Flu Vaccine for patients with acute heart problems

  This trial tests whether giving an influenza vaccine within 24 hours before hospital discharge helps patients who were treated for acute heart issues stay healthier this season.

  Recruiting Phase 4 Wroclaw Medical University · Wroclaw · NCT07617376

• Acute Heart Failure: How a Quantitative ECG Helps Clinicians

  This study tests whether quantitative ECG (QCG) measurements can reveal useful patterns in adults hospitalized with acute heart failure.

  Recruiting Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07601022

• Urinary Sodium and Chloride Changes and Fluid Overload in Acute Heart Failure

  This study tests whether tracking urinary sodium and chloride during hospitalization can reflect congestion removal and predict short-term outcomes in adults with acute heart failure treated with IV diuretics.

  Recruiting Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Olot, Girona and 3 other locations · NCT07597512

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.