ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure (NCT07484009) | Clinical Trial Compass
RecruitingNot Applicable
ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure
Spain1,014 participantsStarted 2026-01-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with an efficacy event at 1 month after discharge
Timeframe: From randomization to the end of follow-up at 1 month after hospitalization discharge
2
Number of participant with a safety event at 1 month after discharge
Timeframe: From randomization to the end of follow-up at 1 month after hospitalization discharge
Trial details
NCT IDNCT07484009
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
. 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.