Acute Heart Failure (AHF)ReDS-SAFE HF 2NCT07484009
ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure
A study testing Remote Dielectric Sensing System and Blinded ReDS data in people with Acute Heart Failure (AHF) and Heart Failure (for Example, Fluid Overload), run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 25 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Heart Failure (for Example, Fluid Overload), Heart Failure Hospitalization
- What is being tested?
- Remote Dielectric Sensing System and Blinded ReDS data
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,014 participants
- Where
- 25 sitesSpain
- Study dates
- 29 Jan 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Rey Iborra, BSN contact
25 sites in 1 country
Spain25 sites, 25 recruiting
- Not yet recruiting
Arnau de Vilanova University Hospital
Barcelona
Ramón Bascompte Claret, MD, PhD, 34 961 97 60 00, rbascompte.lleida.ics@gencat.cat
- Recruiting
Bellvitge University Hospital
Barcelona
Herminio Morillas Climent, MD, PhD, 34 932 60 75 00, herminiomorillas@bellvitgehospital.cat
- Not yet recruiting
Hospital Clinic
Barcelona
Eduard Solé González, MD, PhD, 34 932 27 54 00, edsole@clinic.cat
- Recruiting
Hospital del Mar
Barcelona
Sandra Valdivielso Moré, MD, PhD, 34 932 48 30 00, svaldivielso@hmar.cat
- Not yet recruiting
Vall d'Hebrón University Hospital
Barcelona
Toni Soriano Colomé, MD, PhD, 34 934 89 30 00, tonisorianocolome@gmail.com
- Recruiting
Reina Sofía University Hospital
Córdoba
Manuel Pérez Anguita, MD, PhD, 34 911 91 40 00, manuelp.anguita.sspa@juntadeandalucia.es
- Recruiting
Dr Josep Trueta University Hospital
Girona
Aleix Tort Pal, MD, PhD, 34 972 94 02 00, afort.girona.ics@gencat.cat
- Recruiting
Ramón y Cajal University Hospital
Madrid, Madrid, 28034
Jesús Álvarez-García, MD, PhD, 34 677495661, jalvarezg82@gmail.com
Cristina Rey Iborra, BSN, creyi@salud.madrid.org
- Recruiting
12 de Octubre University Hospital
Madrid
Laura Morán Fernandez, MD, 34 913 90 80 00, lauramoranfernandez@gmail.com
- Not yet recruiting
Clínico San Carlos University Hospital
Madrid
Josebe Goirigolzarri Artaza, MD, PhD, 34 913 30 30 00, josebegoiri@gmail.com
- Not yet recruiting
Fundación Jiménez Díaz University Hospital
Madrid
Mikel Taibo Urquía, MD, PhD, 34 915 50 48 00, Mikel.taibo@fjd.es
- Not yet recruiting
Gregorio Marañón University Hospital
Madrid
Zorba Blázquez Bermejo, MD, PhD, 34 915 86 80 00, zorbablbe@gmail.com
- Recruiting
La Paz University Hospital
Madrid
Angel Iniesta Manjavacas, MD, PhD, 34 917 27 70 00, a.m.iniesta84@gmail.com
- Not yet recruiting
La Princesa University Hospital
Madrid
Pablo Díez Villanueva, MD, PhD, 34 915 20 22 00, pdiezvillanueva@secardiologia.es
- Recruiting
Puerta de Hierro Majadahonda University Hospital
Madrid
Mercedes Rivas-Lasarte, MD, PhD, 34 911 91 60 00, rivaslasarte@gmail.com
- Recruiting
Virgen de la Victoria University Hospital
Málaga
Ainhoa Robles Mezcua, MD, PhD, 34 951 03 20 00, ainhoa.mezcua@gmail.com
- Not yet recruiting
Virgen de la Arrixaca
Murcia
Noelia Fernández Villa, MD, 34 968 36 95 00, noelia.fernandez7@um.es
- Not yet recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca
David González Calle, MD, PhD, 34 923 29 11 00, davidgonzalezcalle@gmail.com
- Recruiting
San Juan Despí Moisès Broggi Hospital
Sant Joan Despí
Román Freixa Pamies, MD, PhD, roman.freixa@sanitatintegral.org
- Not yet recruiting
Marqués de Valdecilla University Hospital
Santander
Gonzalo Martín Gorrria, MD, 34 942 20 25 20, gonzalo.martin@scsalud.es
- Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Inés Gómez Otero, MD, PhD, 34 981 95 00 00, mgo300971@gmail.com
- Not yet recruiting
Virgen de la Macarena University Hospital
Seville
Alejandro Recio Mayoral, MD, PhD, 34 955 00 80 00, recioalejandro@yahoo.es
- Not yet recruiting
Sant Joan XXIII University Hospital
Tarragona
María Ferrero Guillem, MD, 34 977 29 58 00, mariaferrero23@gmail.com
- Not yet recruiting
Hospital General Universitario de Toledo
Toledo
Marta Flores Hernáne¡, MD, 34 925 26 92 00, flores13marta@gmail.com
- Not yet recruiting
Clínico University Hospital
Valencia
Julio Núñez Villota, MD, PhD, 34 961 97 35 00, yulnunez@gmail.com
About this study
Official title: ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial
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:
Read more
- Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge?
- 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.
- Conditions
- Acute Heart Failure (AHF), Heart Failure (for Example, Fluid Overload), Heart Failure Hospitalization
- Being tested
- Remote Dielectric Sensing System, Blinded ReDS data
- Keywords
- Heart failure, Congestion, ReDS, Fluid Overload, Randomized Clinical Trial
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Dielectric Sensing SystemDevice
The ReDS system consists of 2 sensors that are placed (sitting or supine) on the front (infraclavicular) and back (below the scapula) of the patient's right hemithorax and in 45 seconds accurately quantifies the proportion of fluid in the lung. The sensors are connected via 1 cable to a touchscreen monitor that easily guides the measurement process and stores this information. The accuracy of this technology has been validated with high-resolution chest computed tomography and invasive hemodynamic measurements with a Swan-Ganz catheter. Normal ReDS values range between 20% and 35% (i.e., 20-35% of the lung would be fluid). Above 35% is considered congestive, whereas below 20% the lung would be "dry" or dehydrated.
Blinded ReDS dataDevice
The responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| ReDS-guided strategy | Experimental | Each day, the clinician responsible for the patient will have access to the ReDS value and will adjust the treatment according to the study's diuretic protocol. The responsible physician can discharge the patient if the clinical stability criteria are met, and the ReDS value is below 35% and a relative reduction of 10% or more from the admission ReDS value has been achieved (i.e. a patient admitted with a ReDS value of 36% should be discharged with a ReDS of 32% at least; or a patient admitted with a ReDS of 34% should be discharged with a ReDS of 31% at least). If the ReDS criteria are not met, the patient should remain hospitalized for another day until these conditions are met. Clinical stability is defined as the presence of at least 2 of the following 3 conditions: i) discharge weight lower than admission weight, ii) at least a 30% reduction in natriuretic peptide from admission, and iii) a score <2 in the Orthoedema score Receives: Device: Remote Dielectric Sensing System |
| Usual clinical practice strategy | Sham comparator | The responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met. Receives: Device: Blinded ReDS data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an efficacy event at 1 month after discharge
The primary outcome measure is the combined event rate of all-cause mortality, HF readmission, and/or unexpected HF visits requiring diuretic adjustment at 1 month after discharge
Measured: From randomization to the end of follow-up at 1 month after hospitalization discharge
Number of participant with a safety event at 1 month after discharge
The primary outcome measure is the combined event rate of symptomatic systolic hypotension (<90 mmHg), electrolyte imbalances (potassium below 3 or above 5.5 meq/L), and/or worsening of renal function compared to the baseline visit at the first post-discharge outpatient visit (at least 50% reduction in glomerular filtration rate).
Measured: From randomization to the end of follow-up at 1 month after hospitalization discharge
Secondary outcomes (1)
Cost-efficacy outcome measure
Length of stay and cost of ReDS device
Measured: Length of stay of index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start29 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,014 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal, Hospital Universitario 12 de Octubre, Hospital San Carlos, Madrid, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hospital Universitari de Bellvitge, Hospital del Mar, Hospital de Sant Joan Despí Moisès Broggi, Hospital Arnau de Vilanova, Hospital Universitario Virgen de la Arrixaca, Complejo Hospitalario Universitario de Santiago, Salamanca University Hospital, Complejo Hospitalario Toledo, Hospital Universitario Virgen Macarena, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Victoria, Hospital Universitario Marqués de Valdecilla, Hospital Clínico Universitario de Valencia, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Puerta de Hierro University Hospital, La Princesa University Hospital Madrid, University Hospital of Girona Dr. Josep Trueta, Joan XXIII University Hospital
- Responsible party
- Principal investigator, Jesus Alvarez-Garcia, Hospital Universitario Ramon y Cajal
- Investigators
- Jesús Álvarez-García, MD, PhD, Principal investigator, Ramón y Cajal University Hospital, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484009
- Sponsor's protocol ID
- 208/24
- Other IDs
- PI24/01541, SEC/FEC-INV-CLI 24/17
- Acronym
- ReDS-SAFE HF 2
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Lala A, Barghash MH, Giustino G, Alvarez-Garcia J, Konje S, Parikh A, Ullman J, Keith B, Donehey J, Mitter SS, Trivieri MG, Contreras JP, Burkhoff D, Moss N, Mancini DM, Pinney SP. Early use of remote dielectric sensing after hospitalization to reduce heart failure readmissions. ESC Heart Fail. 2021 Apr;8(2):1047-1054. doi: 10.1002/ehf2.13026. Epub 2020 Dec 18.
PubMed 33336881Alvarez-Garcia J, Lala A, Rivas-Lasarte M, De Rueda C, Brunjes D, Lozano-Jimenez S, Garcia-Sebastian C, Mitter S, Remior P, Jimenez-Blanco Bravo M, Del Prado S, Barghash M, Gonzalez-Ferrer E, Ullman J, Cobo M, Segovia-Cubero J, Zamorano JL, Pinney SP, Mancini D. Remote Dielectric Sensing Before and After Discharge in Patients With ADHF: The ReDS-SAFE HF Trial. JACC Heart Fail. 2024 Apr;12(4):695-706. doi: 10.1016/j.jchf.2024.01.002. Epub 2024 Feb 28.
PubMed 38430084
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial
- ClinicalTrials.gov ID
- NCT07484009
- Acronym / sponsor ID
- ReDS-SAFE HF 2 / 208/24
- Conditions
- Acute Heart Failure (AHF), Heart Failure (for Example, Fluid Overload), Heart Failure Hospitalization
- Keywords
- Heart failure, Congestion, ReDS, Fluid Overload, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,014 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal, Hospital Universitario 12 de Octubre, Hospital San Carlos, Madrid, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hospital Universitari de Bellvitge, Hospital del Mar, Hospital de Sant Joan Despí Moisès Broggi, Hospital Arnau de Vilanova, Hospital Universitario Virgen de la Arrixaca, Complejo Hospitalario Universitario de Santiago, Salamanca University Hospital, Complejo Hospitalario Toledo, Hospital Universitario Virgen Macarena, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Victoria, Hospital Universitario Marqués de Valdecilla, Hospital Clínico Universitario de Valencia, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Puerta de Hierro University Hospital, La Princesa University Hospital Madrid, University Hospital of Girona Dr. Josep Trueta, Joan XXIII University Hospital
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReDS-guided strategy | Experimental | Device: Remote Dielectric Sensing SystemEach day, the clinician responsible for the patient will have access to the ReDS value and will adjust the treatment according to the study's diuretic protocol. The responsible physician can discharge the patient if the clinical stability criteria are met, and the ReDS value is below 35% and a relative reduction of 10% or more from the admission ReDS value has been achieved (i.e. a patient admitted with a ReDS value of 36% should be discharged with a ReDS of 32% at least; or a patient admitted with a ReDS of 34% should be discharged with a ReDS of 31% at least). If the ReDS criteria are not met, the patient should remain hospitalized for another day until these conditions are met. Clinical stability is defined as the presence of at least 2 of the following 3 conditions: i) discharge weight lower than admission weight, ii) at least a 30% reduction in natriuretic peptide from admission, and iii) a score <2 in the Orthoedema score |
| Usual clinical practice strategy | Sham comparator | Device: Blinded ReDS dataThe responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Dielectric Sensing SystemThe ReDS system consists of 2 sensors that are placed (sitting or supine) on the front (infraclavicular) and back (below the scapula) of the patient's right hemithorax and in 45 seconds accurately quantifies the proportion of fluid in the lung. The sensors are connected via 1 cable to a touchscreen monitor that easily guides the measurement process and stores this information. The accuracy of this technology has been validated with high-resolution chest computed tomography and invasive hemodynamic measurements with a Swan-Ganz catheter. Normal ReDS values range between 20% and 35% (i.e., 20-35% of the lung would be fluid). Above 35% is considered congestive, whereas below 20% the lung would be "dry" or dehydrated. | Device | ReDS-guided strategy |
| Blinded ReDS dataThe responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met. | Device | Usual clinical practice strategy |
Primary outcome
Number of participants with an efficacy event at 1 month after discharge
Time frame: From randomization to the end of follow-up at 1 month after hospitalization discharge
The primary outcome measure is the combined event rate of all-cause mortality, HF readmission, and/or unexpected HF visits requiring diuretic adjustment at 1 month after discharge
Number of participant with a safety event at 1 month after discharge
Time frame: From randomization to the end of follow-up at 1 month after hospitalization discharge
The primary outcome measure is the combined event rate of symptomatic systolic hypotension (<90 mmHg), electrolyte imbalances (potassium below 3 or above 5.5 meq/L), and/or worsening of renal function compared to the baseline visit at the first post-discharge outpatient visit (at least 50% reduction in glomerular filtration rate).
1 secondary outcome
Cost-efficacy outcome measure
Time frame: Length of stay of index admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 33336881Lala A, Barghash MH, Giustino G, Alvarez-Garcia J, Konje S, Parikh A, Ullman J, Keith B, Donehey J, Mitter SS, Trivieri MG, Contreras JP, Burkhoff D, Moss N, Mancini DM, Pinney SP. Early use of remote dielectric sensing after hospitalization to reduce heart failure readmissions. ESC Heart Fail. 2021 Apr;8(2):1047-1054. doi: 10.1002/ehf2.13026. Epub 2020 Dec 18.
- Background: PubMed 38430084Alvarez-Garcia J, Lala A, Rivas-Lasarte M, De Rueda C, Brunjes D, Lozano-Jimenez S, Garcia-Sebastian C, Mitter S, Remior P, Jimenez-Blanco Bravo M, Del Prado S, Barghash M, Gonzalez-Ferrer E, Ullman J, Cobo M, Segovia-Cubero J, Zamorano JL, Pinney SP, Mancini D. Remote Dielectric Sensing Before and After Discharge in Patients With ADHF: The ReDS-SAFE HF Trial. JACC Heart Fail. 2024 Apr;12(4):695-706. doi: 10.1016/j.jchf.2024.01.002. Epub 2024 Feb 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Rey Iborra, BSN contact
Jesús Álvarez-García, MD, PhD principal investigator
Ramón y Cajal University Hospital, Madrid, Spain
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Dielectric Sensing System and Blinded ReDS data in people with Acute Heart Failure (AHF) and Heart Failure (for Example, Fluid Overload), run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 25 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesús Álvarez-García, MD, PhD (34 667495661, jalvarezg82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with an efficacy event at 1 month after discharge (time frame: From randomization to the end of follow-up at 1 month after hospitalization discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07484009, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.