Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PI24/01541 | Other Grant/Funding Number | Carlos III Institute of Health (Ministry of Science, Innovation and University of Spain) | |
| SEC/FEC-INV-CLI 24/17 | Other Grant/Funding Number | Spanish Society of Cardiology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Universitario Ramon y Cajal | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
| Hospital San Carlos, Madrid | OTHER |
| Hospital Universitario Fundación Jiménez Díaz |
Not provided
Not provided
Not provided
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:
Researchers will compare the ReDS-based strategy against the current standard of care. All participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Dielectric Sensing System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | From randomization to the end of follow-up at 1 month after hospitalization discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-efficacy outcome measure | Length of stay and cost of ReDS device | Length of stay of index admission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
A third of females of total will be required
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesús Álvarez-García, MD, PhD | Contact | 34 667495661 | jalvarezg82@gmail.com | |
| Cristina Rey Iborra, BSN | Contact | creyi@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Jesús Álvarez-García, MD, PhD | Ramón y Cajal University Hospital, Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramón y Cajal University Hospital | Recruiting | Madrid | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33336881 | Background | 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. | |
| 38430084 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Hospital Universitario La Paz | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hospital Vall d'Hebron | OTHER |
| Hospital Universitari de Bellvitge | OTHER |
| Hospital del Mar | OTHER |
| Hospital Sant Joan Despí Moisès Broggi | UNKNOWN |
| Hospital Arnau de Vilanova | OTHER |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Complejo Hospitalario Universitario de Santiago | OTHER |
| Salamanca University Hospital | OTHER |
| Complejo Hospitalario Toledo | OTHER |
| Hospital Universitario Virgen Macarena | OTHER |
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
| Hospital Universitario Virgen de la Victoria | OTHER |
| Hospital Universitario Marqués de Valdecilla | OTHER |
| Hospital Clínico Universitario de Valencia | OTHER |
| Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III | OTHER |
| Puerta de Hierro University Hospital | OTHER |
| La Princesa University Hospital Madrid | UNKNOWN |
| University Hospital of Girona Dr. Josep Trueta | NETWORK |
| Joan XXIII University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Blinded ReDS data | Device | 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. |
|
| Arnau de Vilanova University Hospital | Not yet recruiting | Barcelona | Spain |
|
| Bellvitge University Hospital | Recruiting | Barcelona | Spain |
|
| Hospital Clinic | Not yet recruiting | Barcelona | Spain |
|
| Hospital del Mar | Recruiting | Barcelona | Spain |
|
| Vall d'Hebrón University Hospital | Not yet recruiting | Barcelona | Spain |
|
| Reina Sofía University Hospital | Recruiting | Córdoba | Spain |
|
| Dr Josep Trueta University Hospital | Recruiting | Girona | Spain |
|
| 12 de Octubre University Hospital | Recruiting | Madrid | Spain |
|
| Clínico San Carlos University Hospital | Not yet recruiting | Madrid | Spain |
|
| Fundación Jiménez Díaz University Hospital | Not yet recruiting | Madrid | Spain |
|
| Gregorio Marañón University Hospital | Not yet recruiting | Madrid | Spain |
|
| La Paz University Hospital | Recruiting | Madrid | Spain |
|
| La Princesa University Hospital | Not yet recruiting | Madrid | Spain |
|
| Puerta de Hierro Majadahonda University Hospital | Recruiting | Madrid | Spain |
|
| Virgen de la Victoria University Hospital | Recruiting | Málaga | Spain |
|
| Virgen de la Arrixaca | Not yet recruiting | Murcia | Spain |
|
| Complejo Asistencial Universitario de Salamanca | Not yet recruiting | Salamanca | Spain |
|
| San Juan Despí Moisès Broggi Hospital | Recruiting | Sant Joan Despí | Spain |
|
| Marqués de Valdecilla University Hospital | Not yet recruiting | Santander | Spain |
|
| Complejo Hospitalario Universitario de Santiago | Recruiting | Santiago de Compostela | Spain |
|
| Virgen de la Macarena University Hospital | Not yet recruiting | Seville | Spain |
|
| Sant Joan XXIII University Hospital | Not yet recruiting | Tarragona | Spain |
|
| Hospital General Universitario de Toledo | Not yet recruiting | Toledo | Spain |
|
| Clínico University Hospital | Not yet recruiting | Valencia | Spain |
|
| Alvarez-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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided