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
- Diseases
- Heart failure
- 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
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Arnau de Vilanova University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Vall d'Hebron University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Reina Sofia University Hospital Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Dr Josep Trueta University Hospital Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Puerta de Hierro Majadahonda University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Gregorio Marañón University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| 12 de Octubre University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínico San Carlos University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Ramón y Cajal University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Fundación Jiménez Díaz University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| La Paz University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| La Princesa University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Virgen de la Victoria University Hospital Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Not yet recruiting |
| Marqués de Valdecilla University Hospital Coordinator of this site? Confirm its status | Santander | Spain | Not yet recruiting |
| Complejo Hospitalario Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| San Juan Despí Moisès Broggi Hospital Coordinator of this site? Confirm its status | Sant Joan Despí | Spain | Recruiting |
| Virgen de la Macarena University Hospital Coordinator of this site? Confirm its status | Seville | Spain | Not yet recruiting |
| Sant Joan XXIII University Hospital Coordinator of this site? Confirm its status | Tarragona | Spain | Not yet recruiting |
| Hospital General Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Not yet recruiting |
| Clínico University Hospital Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.