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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)
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

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
H.U. A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainNot yet recruiting
Hospital General Universitario Dr. Balmis
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
H Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
H.U. de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
H.U. Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
H.U. Germans Trias i Pujol
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
H.U. Josep Trueta
Coordinator of this site? Confirm its status
GironaSpainRecruiting
H.U. Virgen de las Nieves
Coordinator of this site? Confirm its status
GranadaSpainNot yet recruiting
H.U. de Bellvitge
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Arnau de Vilanova
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LleidaSpainRecruiting
H. Clinico San Carlos
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainNot yet recruiting
H.G.U. Gregorio Marañón
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MadridSpainRecruiting
H.U. 12 de Octubre
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MadridSpainRecruiting
H.U. Ramón y Cajal
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MadridSpainNot yet recruiting
H.U. Puerta de Hierro
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MajadahondaSpainRecruiting
H.U. Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
H.C.U. Virgen de la Arrixaca
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MurciaSpainRecruiting
H.U. Central de Asturias
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OviedoSpainRecruiting
H.U. Son Llátzer
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Palma de MallorcaSpainRecruiting
Complejo Hospitalario de Navarra
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PamplonaSpainRecruiting
Hospital Parc Tauli
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SabadellSpainNot yet recruiting
H.U de Salamanca
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SalamancaSpainRecruiting
H.C.U de Santiago de Compostela
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Santiago de CompostelaSpainRecruiting
H.U. Virgen del Rocío
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SevilleSpainRecruiting
Complejo Hospitalario Universitario de Toledo
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ToledoSpainNot yet recruiting
H.U. Politécnico de la Fe
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ValenciaSpainRecruiting
Hospital General Universitario de Valencia
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ValenciaSpainNot yet recruiting
H.C.U de Valencia
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ValenciaSpainNot yet recruiting
H.C.U de Valladolid
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ValladolidSpainRecruiting
H.U. Miguel Servet
Coordinator of this site? Confirm its status
ZaragozaSpainNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.