Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT06055504
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '4 years'}, {'measure': 'SCD', 'timeFrame': '4 years'}, {'measure': 'Hospitalisation for device-related complications', 'timeFrame': '4 years'}, {'measure': 'Non-fatal major arrhythmic events', 'timeFrame': '4 years'}, {'measure': 'cost-effectiveness', 'timeFrame': '4 years', '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 \\]\n\nThe 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.'}, {'measure': 'Quality of life assessed by KCCQ, EQ-5D and HADS', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-ischemic Dilated Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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%', 'detailedDescription': '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%\n\nRandomization will be 1:1 and patients are allocated to either control strategy or intervention strategy.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening.\n* Previously established diagnosis of Non-ischemic DCM\n* Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.\n* NYHA functional class II-III.\n* LVEF ≤ 35% documented by CMR as study procedure.\n* Life expectancy greater than 12 months.\n\nExclusion Criteria:\n\n* 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)\n* Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.\n* Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.\n* History of recovered sudden death or sustained ventricular tachycardia.\n* NYHA functional class IV.\n* Waiting list for cardiac transplantation in emergency 0.\n* Receiver of a solid organ transplant (lung, liver, heart or kidney).'}, 'identificationModule': {'nctId': 'NCT06055504', 'briefTitle': 'Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Consorcio Centro de Investigación Biomédica en Red (CIBER)'}, 'officialTitle': 'Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)', 'orgStudyIdInfo': {'id': 'SPANISH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Strategy', 'interventionNames': ['Other: Control Strategy']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized precision ICD implantation Strategy based in genetic findings and CMR results', 'interventionNames': ['Other: Personalized precision ICD implantation Strategy based in genetic findings and CMR results']}], 'interventions': [{'name': 'Control Strategy', 'type': 'OTHER', 'description': 'ICDs will be implanted in all patients according to current recommendations', 'armGroupLabels': ['Control Strategy']}, {'name': 'Personalized precision ICD implantation Strategy based in genetic findings and CMR results', 'type': 'OTHER', '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.', 'armGroupLabels': ['Personalized precision ICD implantation Strategy based in genetic findings and CMR results']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'J. Ramón González-Juanatey', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.C.U de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José González Costello', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Amadeo Marcelo Rizzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Generosa Crespo Leiro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo García Pavía', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rebeca Lorca Gutiérrez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '03010', 'city': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Gabriel Martínez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario Dr Balmis', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José M Guerra Ramos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Josep Lluis Mont Girbau', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H. Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antoni Bayés Genís', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Nuria Rivas Gándara', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "H.U. Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Girona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ramón Brugada Terradellas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18014', 'city': 'Granada', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Jiménez Jáimez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '25198', 'city': 'Lleida', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jara Gayán Ordás', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Bermejo Thomas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.G.U. Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Jiménez-Blanco Bravo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Victoria Cañadas Godoy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H. Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Borja Ibáñez Cabeza', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Arribas Ynsaurriaga', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Manuel García-Pinilla', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30120', 'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Domingo Pascual Figal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.C.U. Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Tomás Ripoll Vera', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Son Llátzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Teresa Basurte Elorz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Luis Sánchez Fernández', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eduardo Arana Rueda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '45007', 'city': 'Toledo', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miguel Ángel Arias Palomares', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario Universitario de Toledo', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46010', 'city': 'Valencia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Julio Núñez Villota', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.C.U de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46010', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Martínez Dolz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Politécnico de la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Aurelio Quesada Dorador', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47003', 'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Alberto San Román Calvar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.C.U de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '50009', 'city': 'Zaragoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria del Rosario Ortas Nadal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.U. Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Maria de la Iglesia', 'role': 'CONTACT', 'email': 'spanish-i@cibercv.es', 'phone': '+34911916749'}, {'name': 'Projects Department (CIBER)', 'role': 'CONTACT', 'email': 'proyectos@ciberisciii.es', 'phone': '+34 91 822 28 74'}], 'overallOfficials': [{'name': 'Pablo García Pavía', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H.U. Puerta de Hierro, Majadahonda'}, {'name': 'Antoni Bayés Genís', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H.U. Germans Trias i Pujol'}, {'name': 'Javier Bermejo Thomas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H.G.U. Gregorio Marañón'}, {'name': 'Javier Díez Martínez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorcio Centro de Investigación Biomédica en Red (CIBER)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}