Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)

Last updated: February 26, 2024
Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Circulation Disorders

Heart Failure

Treatment

Personalized precision ICD implantation Strategy based in genetic findings and CMR results

Control Strategy

Clinical Study ID

NCT06055504
SPANISH-1
  • Ages > 18
  • All Genders

Study Summary

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%

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 tothe screening date.
  • NYHA functional class II-III.
  • LVEF ≤ 35% documented by CMR as study procedure.
  • Life expectancy greater than 12 months.

Exclusion

Exclusion Criteria:

  • History of coronary artery disease justifying the presence of ventricular dysfunction,defined as: history of coronary revascularisation or presence of significant coronarystenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive ornon-invasive coronary angiography (coronary CT)
  • Left ventricular dysfunction attributed to congenital heart disease, valvular disease,alcohol abuse or chemotherapy.
  • Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictivepericarditis.
  • History of recovered sudden death or sustained ventricular tachycardia.
  • NYHA functional class IV.
  • Waiting list for cardiac transplantation in emergency 0.
  • Receiver of a solid organ transplant (lung, liver, heart or kidney).

Study Design

Total Participants: 900
Treatment Group(s): 2
Primary Treatment: Personalized precision ICD implantation Strategy based in genetic findings and CMR results
Phase:
Study Start date:
September 06, 2023
Estimated Completion Date:
October 01, 2027

Study Description

Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for SCD prevention in patients with non-ischemic dilated cardiomyopathy with LVEF≤35%

Randomization will be 1:1 and patients are allocated to either control strategy or intervention strategy.

In the control strategy group, patients will get an Implantable Cardioverter Defibrillator (ICD) implanted. Patients allocated to the intervention strategy will receive an ICD according to genetic and CMR results. ICD implantation criteria in patients allocated to the personalised strategy group will be the presence of either a Dilated Cardiomyopathy DCM-causing pathogenic or likely pathogenic genetic variants or Late Gadolinium Enhancement (LGE) in Cardiac Magnetic Resonance (CMR). Patients without DCM-associated genetic variants and without LGE on CMR will not receive standard treatment but an ICD will not be implanted on them.

Connect with a study center

  • H.C.U de Santiago de Compostela

    Santiago De Compostela, A Coruña 15706
    Spain

    Active - Recruiting

  • H.U. Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • H.U. de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Parc Taulí

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • H.U. A Coruña

    A Coruña, La Coruña 15006
    Spain

    Site Not Available

  • H.U. Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital General Universitario Dr Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

  • H. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • H.U. Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • H.U. Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • H.U. de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • H.U. Josep Trueta

    Gerona, 17007
    Spain

    Active - Recruiting

  • H.U. Virgen de las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova

    Lérida, 25198
    Spain

    Active - Recruiting

  • H. Clínico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • H.G.U. Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • H.U. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • H.U. Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • H.C.U. Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • H.U. Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • H.U. Son Llátzer

    Palma De Mallorca, 07198
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • H.U de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • H.U. Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Toledo

    Toledo, 45007
    Spain

    Site Not Available

  • H.C.U de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • H.U. Politécnico de la Fe

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • H.C.U de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • H.U. Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.