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

Non-ischemic Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055504
• Other study ID #: SPANISH-1
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: October 1, 2027

Study information

• Verified date: February 2024
• Source: Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Contact: Maria de la Iglesia
• Phone: +34911916749
• Email: spanish-i[@]cibercv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• 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.
• Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
• 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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Heart Failure
• Non-ischemic Dilated Cardiomyopathy

Intervention

Other:
• Control Strategy
ICDs will be implanted in all patients according to current recommendations
• Personalized precision ICD implantation Strategy based in genetic findings and CMR results
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 DCM-causing pathogenic or likely pathogenic genetic variants or LGE in 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.

Locations

Country	Name	City	State
Spain	H.U. A Coruña	A Coruña	La Coruña
Spain	Hospital General Universitario Dr Balmis	Alicante
Spain	H. Clinic de Barcelona	Barcelona
Spain	H.U. de la Santa Creu i Sant Pau	Barcelona
Spain	H.U. Germans Trias i Pujol	Barcelona
Spain	H.U. Vall d'Hebron	Barcelona
Spain	H.U. Josep Trueta	Gerona
Spain	H.U. Virgen de las Nieves	Granada
Spain	H.U. de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Arnau de Vilanova	Lérida
Spain	H. Clínico San Carlos	Madrid
Spain	H.G.U. Gregorio Marañón	Madrid
Spain	H.U. 12 de Octubre	Madrid
Spain	H.U. Ramón y Cajal	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	H.U. Puerta de Hierro	Majadahonda	Madrid
Spain	H.U. Virgen de la Victoria	Málaga
Spain	H.C.U. Virgen de la Arrixaca	Murcia
Spain	H.U. Central de Asturias	Oviedo	Asturias
Spain	H.U. Son Llátzer	Palma De Mallorca
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	H.U de Salamanca	Salamanca
Spain	H.C.U de Santiago de Compostela	Santiago De Compostela	A Coruña
Spain	H.U. Virgen del Rocio	Sevilla
Spain	Complejo Hospitalario Universitario de Toledo	Toledo
Spain	H.C.U de Valencia	Valencia
Spain	H.U. Politécnico de la Fe	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	H.C.U de Valladolid	Valladolid
Spain	H.U. Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.		4 years
Secondary	All-cause death		4 years
Secondary	SCD		4 years
Secondary	Hospitalisation for device-related complications		4 years
Secondary	Non-fatal major arrhythmic events		4 years
Secondary	cost-effectiveness	Incremental Cost-effectiveness ratio (ICER) of personalized ICD allocation strategy in non-ischemic DCM [ Time Frame: The time horizon of the evaluation will be limited to 4 years ]; The ICER of the personalized ICD allocation strategy compared with standard strategy is defined as the ratio between the variation in costs and the variation in effectiveness between both strategy groups. In the personalized strategy group, costs will include those related to personalization tests (CMR and genetic analysis) plus costs related to implanting and carrying an ICD (in the number of patients who eventually receive a device). In the control group, costs will include only the latter concept. Costs will be measured in Euros. The variation in effectiveness will be measured both in terms of life years gained, measured in years, and in terms of quality of life gained, measured in QALY. In the first case, ICER will be measured as Euros/year; in the second, it will be measured as Euros/QALY.	4 years
Secondary	Quality of life assessed by KCCQ, EQ-5D and HADS		4 years