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NCT07484009Recruiting

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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

Source: ClinicalTrials.gov · Last updated 19 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1014 (estimated)
First submitted
6 Mar 2026
Start date
29 Jan 2026
Primary completion date
30 Jun 2027
Lead sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
NCT number
NCT07484009

What you commit to

  • Study type: Interventional
  • Planned participants: 1014
  • From 29 Jan 2026 to the primary completion date, 30 Jun 2027
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • 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.

Lab values

  • Chronic kidney disease with a GFR \<20 or on hemodialysis.

Other

  • Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
  • Life expectancy less than 12 months due to non-cardiological origin.
  • Participation in another clinical trial with intervention.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Clinic
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Bellvitge University Hospital
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Arnau de Vilanova University Hospital
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Vall d'Hebron University Hospital
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Reina Sofia University Hospital
Coordinator of this site? Confirm its status
CórdobaSpainRecruiting
Dr Josep Trueta University Hospital
Coordinator of this site? Confirm its status
GironaSpainRecruiting
Puerta de Hierro Majadahonda University Hospital
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Gregorio Marañón University Hospital
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
12 de Octubre University Hospital
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Clínico San Carlos University Hospital
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Ramón y Cajal University Hospital
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Fundación Jiménez Díaz University Hospital
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MadridSpainNot yet recruiting
La Paz University Hospital
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MadridSpainRecruiting
La Princesa University Hospital
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MadridSpainNot yet recruiting
Virgen de la Victoria University Hospital
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MálagaSpainRecruiting
Virgen de la Arrixaca
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MurciaSpainNot yet recruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainNot yet recruiting
Marqués de Valdecilla University Hospital
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SantanderSpainNot yet recruiting
Complejo Hospitalario Universitario de Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainRecruiting
San Juan Despí Moisès Broggi Hospital
Coordinator of this site? Confirm its status
Sant Joan DespíSpainRecruiting
Virgen de la Macarena University Hospital
Coordinator of this site? Confirm its status
SevilleSpainNot yet recruiting
Sant Joan XXIII University Hospital
Coordinator of this site? Confirm its status
TarragonaSpainNot yet recruiting
Hospital General Universitario de Toledo
Coordinator of this site? Confirm its status
ToledoSpainNot yet recruiting
Clínico University Hospital
Coordinator of this site? Confirm its status
ValenciaSpainNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.