Acute Heart Failure (AHF), Heart Failure (for Example, Fluid Overload), Heart Failure Hospitalization
Conditions
Keywords
Heart failure, Congestion, ReDS, Fluid Overload, Randomized Clinical Trial
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.
Interventions
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.
DEVICEBlinded ReDS data
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.
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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 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
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with an efficacy event at 1 month after discharge | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-efficacy outcome measure | Length of stay of index admission | Length of stay and cost of ReDS device |
Countries
Spain
Contacts
CONTACTJesús Álvarez-García, MD, PhD
CONTACTCristina Rey Iborra, BSN
PRINCIPAL_INVESTIGATORJesús Álvarez-García, MD, PhD
Ramón y Cajal University Hospital, Madrid, Spain
Outcome results
None listed