NCT07484009 ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure
| NCT ID | NCT07484009 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
| Condition | Acute Heart Failure (AHF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,014 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,014 participants in total. It began in 2026-01-29 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Jesús Álvarez-García, MD, PhD
PRINCIPAL INVESTIGATOR
Ramón y Cajal University Hospital, Madrid, Spain
Frequently Asked Questions
Who can join the NCT07484009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Heart Failure (AHF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07484009 currently recruiting?
Yes, NCT07484009 is actively recruiting participants. Contact the research team at jalvarezg82@gmail.com for enrollment information.
Where is the NCT07484009 trial being conducted?
This trial is being conducted at Madrid, Spain, Barcelona, Spain, Barcelona, Spain, Barcelona, Spain and 11 additional locations.
Who is sponsoring the NCT07484009 clinical trial?
NCT07484009 is sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. The principal investigator is Jesús Álvarez-García, MD, PhD at Ramón y Cajal University Hospital, Madrid, Spain. The trial plans to enroll 1,014 participants.
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