NCT06055504Recruiting
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 24 Apr 2023
- Start date
- 6 Sept 2023
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Diseases
- Heart failure
- NCT number
- NCT06055504
What you commit to
- Study type: Interventional
- Planned participants: 900
- From 6 Sept 2023 to the primary completion date, 1 Oct 2025
- 31 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive or non-invasive coronary angiography (coronary CT)
- Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.
- History of recovered sudden death or sustained ventricular tachycardia.
- Waiting list for cardiac transplantation in emergency 0.
- Receiver of a solid organ transplant (lung, liver, heart or kidney).
Other
- Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
- NYHA functional class IV.
Who the study is looking for
- Age ≥ 18 years at the time of screening.
- Previously established diagnosis of Non-ischemic DCM
- Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.
- NYHA functional class II-III.
- LVEF ≤ 35% documented by CMR as study procedure.
- Life expectancy greater than 12 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| H.U. A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| H Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| H.U. de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| H.U. Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| H.U. Germans Trias i Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| H.U. Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| H.U. Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| H.U. de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| H. Clinico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| H.G.U. Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| H.U. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| H.U. Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| H.U. Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| H.U. Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| H.C.U. Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| H.U. Central de Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| H.U. Son Llátzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Recruiting |
| Complejo Hospitalario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Not yet recruiting |
| H.U de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| H.C.U de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| H.U. Virgen del Rocío Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Complejo Hospitalario Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Not yet recruiting |
| H.U. Politécnico de la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| H.C.U de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| H.C.U de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| H.U. Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.