Actively Recruiting
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Led by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Updated on 2024-02-28
900
Participants Needed
31
Research Sites
212 weeks
Total Duration
On this page
Sponsors
C
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%
CONDITIONS
Official Title
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of screening
- Previously diagnosed with non-ischemic dilated cardiomyopathy
- Receiving optimized medical treatment at maximum tolerated doses for at least 3 months before screening
- New York Heart Association (NYHA) functional class II or III
- Left ventricular ejection fraction (LVEF) of 35% or less confirmed by cardiac magnetic resonance (CMR)
- Life expectancy longer than 12 months
You will not qualify if you...
- History of coronary artery disease causing ventricular dysfunction, including prior coronary revascularization or significant coronary stenosis (≥50% in left main or ≥70% in major epicardial artery) on angiography or coronary CT
- Ventricular dysfunction due to congenital heart disease, valvular disease, alcohol abuse, or chemotherapy
- Hypertrophic or infiltrative cardiomyopathy, active myocarditis, or constrictive pericarditis
- History of recovered sudden death or sustained ventricular tachycardia
- New York Heart Association (NYHA) functional class IV
- On emergency waiting list for cardiac transplantation (status 0)
- Recipient of a solid organ transplant (lung, liver, heart, or kidney)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
H.C.U de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
2
H.U. de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
3
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
Not Yet Recruiting
4
H.U. A Coruña
A Coruña, La Coruña, Spain, 15006
Not Yet Recruiting
5
H.U. Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
6
H.U. Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
7
Hospital General Universitario Dr Balmis
Alicante, Spain, 03010
Actively Recruiting
8
H.U. de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
9
H. Clinic de Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
10
H.U. Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
11
H.U. Vall d'Hebron
Barcelona, Spain
Actively Recruiting
12
H.U. Josep Trueta
Girona, Spain, 17007
Actively Recruiting
13
H.U. Virgen de las Nieves
Granada, Spain, 18014
Not Yet Recruiting
14
Hospital Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
15
H.G.U. Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
16
H.U. Ramón y Cajal
Madrid, Spain, 28034
Not Yet Recruiting
17
H. Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
18
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Not Yet Recruiting
19
H.U. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
20
H.U. Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
21
H.C.U. Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
22
H.U. Son Llátzer
Palma de Mallorca, Spain, 07198
Actively Recruiting
23
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
24
H.U de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
25
H.U. Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
26
Complejo Hospitalario Universitario de Toledo
Toledo, Spain, 45007
Not Yet Recruiting
27
H.C.U de Valencia
Valencia, Spain, 46010
Not Yet Recruiting
28
H.U. Politécnico de la Fe
Valencia, Spain, 46010
Actively Recruiting
29
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Not Yet Recruiting
30
H.C.U de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
31
H.U. Miguel Servet
Zaragoza, Spain, 50009
Not Yet Recruiting
Research Team
M
Maria de la Iglesia
CONTACT
P
Projects Department (CIBER)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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