Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07484009

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2026-03-19

1014

Participants Needed

25

Research Sites

82 weeks

Total Duration

On this page

Sponsors

F

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Lead Sponsor

H

Hospital Universitario Ramon y Cajal

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized due to heart failure as the main reason, including symptoms and signs of congestion, regardless of left ventricular ejection fraction
  • NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission
Not Eligible

You will not qualify if you...

  • Height less than 150 cm or greater than 190 cm or body mass index less than 22 or greater than 39
  • Patients requiring inotropes (except levosimendan), vasopressors, mechanical support, or heart transplant recipients upon admission
  • Any malformation or variant affecting the right lung anatomy (e.g., pacemaker)
  • Planned surgical or percutaneous heart interventions during the trial
  • Chronic kidney disease with GFR less than 20 or on hemodialysis
  • Life expectancy less than 12 months due to non-cardiological causes
  • Participation in another clinical trial with intervention

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Ramón y Cajal University Hospital

Madrid, Madrid, Spain, 28034

Actively Recruiting

2

Arnau de Vilanova University Hospital

Barcelona, Spain

Not Yet Recruiting

3

Bellvitge University Hospital

Barcelona, Spain

Actively Recruiting

4

Hospital Clinic

Barcelona, Spain

Not Yet Recruiting

5

Hospital del Mar

Barcelona, Spain

Actively Recruiting

6

Vall d'Hebrón University Hospital

Barcelona, Spain

Not Yet Recruiting

7

Reina Sofía University Hospital

Córdoba, Spain

Actively Recruiting

8

Dr Josep Trueta University Hospital

Girona, Spain

Actively Recruiting

9

12 de Octubre University Hospital

Madrid, Spain

Actively Recruiting

10

Clínico San Carlos University Hospital

Madrid, Spain

Not Yet Recruiting

11

Fundación Jiménez Díaz University Hospital

Madrid, Spain

Not Yet Recruiting

12

Gregorio Marañón University Hospital

Madrid, Spain

Not Yet Recruiting

13

La Paz University Hospital

Madrid, Spain

Actively Recruiting

14

La Princesa University Hospital

Madrid, Spain

Not Yet Recruiting

15

Puerta de Hierro Majadahonda University Hospital

Madrid, Spain

Actively Recruiting

16

Virgen de la Victoria University Hospital

Málaga, Spain

Actively Recruiting

17

Virgen de la Arrixaca

Murcia, Spain

Not Yet Recruiting

18

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Not Yet Recruiting

19

San Juan Despí Moisès Broggi Hospital

Sant Joan Despí, Spain

Actively Recruiting

20

Marqués de Valdecilla University Hospital

Santander, Spain

Not Yet Recruiting

21

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Actively Recruiting

22

Virgen de la Macarena University Hospital

Seville, Spain

Not Yet Recruiting

23

Sant Joan XXIII University Hospital

Tarragona, Spain

Not Yet Recruiting

24

Hospital General Universitario de Toledo

Toledo, Spain

Not Yet Recruiting

25

Clínico University Hospital

Valencia, Spain

Not Yet Recruiting

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Research Team

J

Jesús Álvarez-García, MD, PhD

CONTACT

C

Cristina Rey Iborra, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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