Heart Failure Clinical Trials

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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Arnau de Vilanova University Hospital
NOT_YET_RECRUITING
Barcelona
Bellvitge University Hospital
RECRUITING
Barcelona
Hospital Clinic
NOT_YET_RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Vall d'Hebrón University Hospital
NOT_YET_RECRUITING
Barcelona
Reina Sofía University Hospital
RECRUITING
Córdoba
Dr Josep Trueta University Hospital
RECRUITING
Girona
12 de Octubre University Hospital
RECRUITING
Madrid
Clínico San Carlos University Hospital
NOT_YET_RECRUITING
Madrid
Fundación Jiménez Díaz University Hospital
NOT_YET_RECRUITING
Madrid
Gregorio Marañón University Hospital
NOT_YET_RECRUITING
Madrid
La Paz University Hospital
RECRUITING
Madrid
La Princesa University Hospital
NOT_YET_RECRUITING
Madrid
Puerta de Hierro Majadahonda University Hospital
RECRUITING
Madrid
Ramón y Cajal University Hospital
RECRUITING
Madrid
Virgen de la Victoria University Hospital
RECRUITING
Málaga
Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Complejo Asistencial Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
San Juan Despí Moisès Broggi Hospital
RECRUITING
Sant Joan Despí
Marqués de Valdecilla University Hospital
NOT_YET_RECRUITING
Santander
Complejo Hospitalario Universitario de Santiago
RECRUITING
Santiago De Compostela
Virgen de la Macarena University Hospital
NOT_YET_RECRUITING
Seville
Sant Joan XXIII University Hospital
NOT_YET_RECRUITING
Tarragona
Hospital General Universitario de Toledo
NOT_YET_RECRUITING
Toledo
Clínico University Hospital
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
Jesús Álvarez-García, MD, PhD
jalvarezg82@gmail.com
34 667495661
Backup
Cristina Rey Iborra, BSN
creyi@salud.madrid.org
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 1014
Treatments
Experimental: ReDS-guided strategy
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
Sham_comparator: Usual clinical practice strategy
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.
Related Therapeutic Areas
Sponsors
Collaborators: Complejo Hospitalario Universitario de Santiago, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Hospital Vall d'Hebron, Centro Nacional de Investigaciones Cardiovasculares Carlos III, University Hospital of Girona Dr. Josep Trueta, Hospital Arnau de Vilanova, Hospital Universitario La Paz, Hospital Universitario Marqués de Valdecilla, Joan XXIII University Hospital, Hospital Universitari de Bellvitge, Puerta de Hierro University Hospital, Hospital Clínico Universitario de Valencia, Hospital Universitario Reina Sofia de Cordoba, Hospital del Mar, Hospital General Universitario Gregorio Marañon, Hospital Sant Joan Despí Moisès Broggi, La Princesa University Hospital Madrid, Hospital Universitario Virgen de la Victoria, Hospital Universitario Fundación Jiménez Díaz, Complejo Hospitalario Toledo, Salamanca University Hospital, Hospital San Carlos, Madrid, Hospital Universitario Ramon y Cajal, Hospital Universitario Virgen Macarena, Hospital Universitario Virgen de la Arrixaca
Leads: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

This content was sourced from clinicaltrials.gov