Non-ischemic Dilated CardiomyopathyNCT06055504
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
A study testing Personalized precision ICD implantation Strategy based in genetic findings and CMR results in people with Non-ischemic Dilated Cardiomyopathy, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 31 sites in Spain.
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% Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ischemic Dilated Cardiomyopathy
- What is being tested?
- Personalized precision ICD implantation Strategy based in genetic findings and CMR results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 31 sitesSpain
- Study dates
- 6 Sep 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
Spain31 sites, 31 recruiting
- Not yet recruiting
H.U. A Coruña
A Coruña, La Coruña, 15006
Maria Generosa Crespo Leiro
- Recruiting
Hospital General Universitario Dr Balmis
Alicante, 03010
Juan Gabriel Martínez
- Recruiting
H.U. de la Santa Creu i Sant Pau
Barcelona, 08025
José M Guerra Ramos
- Not yet recruiting
H. Clinic de Barcelona
Barcelona, 08036
Josep Lluis Mont Girbau
- Recruiting
H.U. Germans Trias i Pujol
Barcelona, 08916
Antoni Bayés Genís
- Recruiting
H.U. Vall d'Hebron
Barcelona
Nuria Rivas Gándara
- Recruiting
H.U. Josep Trueta
Girona, 17007
Ramón Brugada Terradellas
- Not yet recruiting
H.U. Virgen de las Nieves
Granada, 18014
Juan Jiménez Jáimez
- Recruiting
H.U. de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
José González Costello
- Recruiting
Hospital Arnau de Vilanova
Lleida, 25198
Jara Gayán Ordás
- Recruiting
H.G.U. Gregorio Marañón
Madrid, 28007
Javier Bermejo Thomas
- Not yet recruiting
H.U. Ramón y Cajal
Madrid, 28034
Marta Jiménez-Blanco Bravo
- Recruiting
H. Clínico San Carlos
Madrid, 28040
Victoria Cañadas Godoy
- Not yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Borja Ibáñez Cabeza
- Recruiting
H.U. 12 de Octubre
Madrid, 28041
Fernando Arribas Ynsaurriaga
- Recruiting
H.U. Puerta de Hierro
Majadahonda, Madrid, 28222
Pablo García Pavía
- Recruiting
H.U. Virgen de la Victoria
Málaga, 29010
José Manuel García-Pinilla
- Recruiting
H.C.U. Virgen de la Arrixaca
Murcia, 30120
Domingo Pascual Figal
- Recruiting
H.U. Central de Asturias
Oviedo, Principality of Asturias, 33011
Rebeca Lorca Gutiérrez
- Recruiting
H.U. Son Llátzer
Palma de Mallorca, 07198
Tomás Ripoll Vera
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, 31008
Maria Teresa Basurte Elorz
- Not yet recruiting
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Amadeo Marcelo Rizzo
- Recruiting
H.U de Salamanca
Salamanca, 37007
Pedro Luis Sánchez Fernández
- Recruiting
H.C.U de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
J. Ramón González-Juanatey
- Recruiting
H.U. Virgen del Rocio
Seville, 41013
Eduardo Arana Rueda
- Not yet recruiting
Complejo Hospitalario Universitario de Toledo
Toledo, 45007
Miguel Ángel Arias Palomares
- Not yet recruiting
H.C.U de Valencia
Valencia, 46010
Julio Núñez Villota
- Recruiting
H.U. Politécnico de la Fe
Valencia, 46010
Luis Martínez Dolz
- Not yet recruiting
Hospital General Universitario de Valencia
Valencia, 46014
Aurelio Quesada Dorador
- Recruiting
H.C.U de Valladolid
Valladolid, 47003
José Alberto San Román Calvar
- Not yet recruiting
H.U. Miguel Servet
Zaragoza, 50009
Maria del Rosario Ortas Nadal
About this study
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%
Read the 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.
- Conditions
- Non-ischemic Dilated Cardiomyopathy
- Being tested
- Control Strategy, Personalized precision ICD implantation Strategy based in genetic findings and CMR results
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control StrategyOther
ICDs will be implanted in all patients according to current recommendations
Personalized precision ICD implantation Strategy based in genetic findings and CMR resultsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Strategy | Other | Not described Receives: Other: Control Strategy |
| Personalized precision ICD implantation Strategy based in genetic findings and CMR results | Experimental | Not described Receives: Other: Personalized precision ICD implantation Strategy based in genetic findings and CMR results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.
Measured: 4 years
Secondary outcomes (6)
All-cause death
Measured: 4 years
SCD
Measured: 4 years
Hospitalisation for device-related complications
Measured: 4 years
Non-fatal major arrhythmic events
Measured: 4 years
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.
Measured: 4 years
Quality of life assessed by KCCQ, EQ-5D and HADS
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start6 Sep 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ischemic Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Pablo García Pavía, Principal investigator, H.U. Puerta de Hierro, MajadahondaAntoni Bayés Genís, Principal investigator, H.U. Germans Trias i PujolJavier Bermejo Thomas, Principal investigator, H.G.U. Gregorio MarañónJavier Díez Martínez, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055504
- Sponsor's protocol ID
- SPANISH-1
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
- ClinicalTrials.gov ID
- NCT06055504
- Acronym / sponsor ID
- SPANISH-1
- Conditions
- Non-ischemic Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Strategy | Other | Other: Control Strategy |
| Personalized precision ICD implantation Strategy based in genetic findings and CMR results | Experimental | Other: Personalized precision ICD implantation Strategy based in genetic findings and CMR results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control StrategyICDs will be implanted in all patients according to current recommendations | Other | Control Strategy |
| Personalized precision ICD implantation Strategy based in genetic findings and CMR resultsPatients 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. | Other | Personalized precision ICD implantation Strategy based in genetic findings and CMR results |
Primary outcome
Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.
Time frame: 4 years
6 secondary outcomes
All-cause death
Time frame: 4 years
SCD
Time frame: 4 years
Hospitalisation for device-related complications
Time frame: 4 years
Non-fatal major arrhythmic events
Time frame: 4 years
cost-effectiveness
Time frame: 4 years
Quality of life assessed by KCCQ, EQ-5D and HADS
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Non-ischemic Dilated Cardiomyopathy
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Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
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Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction
Active, not recruitingPhase 1
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Heart Failure With Reduced Ejection Fraction
Recruiting
High Fat Diet for Cardiac Metabolic Reprogramming
Non-ischemic Dilated Cardiomyopathy, Heart Failure With Reduced Ejection Fraction
Enrolling by invitation
Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada
Nonischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo García Pavía principal investigator
H.U. Puerta de Hierro, Majadahonda
Antoni Bayés Genís principal investigator
H.U. Germans Trias i Pujol
Javier Bermejo Thomas principal investigator
H.G.U. Gregorio Marañón
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized precision ICD implantation Strategy based in genetic findings and CMR results in people with Non-ischemic Dilated Cardiomyopathy, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 31 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria de la Iglesia (+34911916749, spanish-i@cibercv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.