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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Control Strategy

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

About this trial

This is an interventional prevention trial for Non-ischemic Dilated Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Strategy

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

Arm Description

Outcomes

Primary Outcome Measures

Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.

Secondary Outcome Measures

All-cause death

SCD

Hospitalisation for device-related complications

Non-fatal major arrhythmic events

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.

Quality of life assessed by KCCQ, EQ-5D and HADS

Full Information

NCT ID

NCT06055504

First Posted

April 24, 2023

Last Updated

September 20, 2023

Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Collaborators

Instituto de Salud Carlos III

1. Study Identification

Unique Protocol Identification Number

NCT06055504

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

October 1, 2025 (Anticipated)

Study Completion Date

October 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Collaborators

Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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%

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-ischemic Dilated Cardiomyopathy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Strategy

Arm Type

Other

Arm Title

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

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Control Strategy

Intervention Description

ICDs will be implanted in all patients according to current recommendations

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.

Time Frame

4 years

Secondary Outcome Measure Information:

Title

All-cause death

Time Frame

4 years

Title

SCD

Time Frame

4 years

Title

Hospitalisation for device-related complications

Time Frame

4 years

Title

Non-fatal major arrhythmic events

Time Frame

4 years

Title

cost-effectiveness

Description

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.

Time Frame

4 years

Title

Quality of life assessed by KCCQ, EQ-5D and HADS

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria de la Iglesia

Phone

+34911916749

Email

spanish-i@cibercv.es

First Name & Middle Initial & Last Name or Official Title & Degree

Projects Department (CIBER)

Phone

+34 91 822 28 74

Email

proyectos@ciberisciii.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pablo García Pavía

Organizational Affiliation

H.U. Puerta de Hierro, Majadahonda

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Antoni Bayés Genís

Organizational Affiliation

H.U. Germans Trias i Pujol

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Javier Bermejo Thomas

Organizational Affiliation

H.G.U. Gregorio Marañón

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Javier Díez Martínez

Organizational Affiliation

University of Navarra

Official's Role

Principal Investigator

Facility Information:

Facility Name

H.C.U de Santiago de Compostela

City

Santiago De Compostela

State/Province

A Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

J. Ramón González-Juanatey

Facility Name

H.U. Central de Asturias

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebeca Lorca Gutiérrez

Facility Name

H.U. de Bellvitge

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José González Costello

Facility Name

H.U. A Coruña

City

A Coruña

State/Province

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Generosa Crespo Leiro

Facility Name

H.U. Puerta de Hierro

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pablo García Pavía

Facility Name

H.U. de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José M Guerra Ramos

Facility Name

H. Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Josep Lluis Mont Girbau

Facility Name

H.U. Germans Trias i Pujol

City

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antoni Bayés Genís

Facility Name

H.U. Vall d'Hebron

City

Barcelona

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nuria Rivas Gándara

Facility Name

H.U. Josep Trueta

City

Gerona

ZIP/Postal Code

17007

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramón Brugada Terradellas

Facility Name

H.U. Virgen de las Nieves

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan Jiménez Jáimez

Facility Name

H.G.U. Gregorio Marañón

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

H.U. Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marta Jiménez-Blanco Bravo

Facility Name

H. Clínico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victoria Cañadas Godoy

Facility Name

Hospital Universitario Fundación Jiménez Díaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Borja Ibáñez Cabeza

Facility Name

H.U. 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando Arribas Ynsaurriaga

Facility Name

H.C.U. Virgen de la Arrixaca

City

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Domingo Pascual Figal

Facility Name

H.U. Virgen de la Victoria

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Manuel García-Pinilla

Facility Name

H.U. Son Llátzer

City

Palma De Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomás Ripoll Vera

Facility Name

Complejo Hospitalario de Navarra

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Teresa Basurte Elorz

Facility Name

H.U de Salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Luis Sánchez Fernández

Facility Name

H.U. Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Arana Rueda

Facility Name

Complejo Hospitalario Universitario de Toledo

City

Toledo

ZIP/Postal Code

45007

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miguel Ángel Arias Palomares

Facility Name

H.C.U de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julio Núñez Villota

Facility Name

H.U. Politécnico de la Fe

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Martínez Dolz

Facility Name

H.C.U de Valladolid

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Alberto San Román Calvar

Facility Name

H.U. Miguel Servet

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria del Rosario Ortas Nadal

Non-ischemic Dilated Cardiomyopathy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial