Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05600218
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement (risk profile)', 'timeFrame': '12 months', 'description': 'Percentage of patients reducing annual mortality risk profile according to ESC/ERS Clinical Practice Guidelines 2015 Risk Stratification.'}], 'secondaryOutcomes': [{'measure': 'Risk stratification variables', 'timeFrame': 'Basaline', 'description': 'Percentage of clinical tests that have been used to include study treatment.'}, {'measure': 'Events', 'timeFrame': '12 months', 'description': 'Incidence of events in follow-up: admission for worsening pulmonary hypertension; need for systemic prostacyclins; unscheduled admission for any cause; death related to pulmonary hypertension; death from any cause.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension', 'Selexipag', 'Real World Data', 'Effectiveness'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'This is an observational, ambrispective study of patients in real world clinical practice, who has pulmonary arterial hypertension in whom a prostacyclin IP receptor agonist (Selexipag) is initiated between 2017 and 2021.\n\nThe aim of this study answer the following questions:\n\n* Changes in the mortality risk profile of these patients after treatment administration.\n* Baseline characteristics of patients initiating Selexipag.\n* Parameters used for risk stratification prior to treatment escalation.\n* Events during follow-up.\n\nNo comparison group available'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pulmonary arterial hypertension (mostly intermediate risk patients) who are started on treatment with Selexipag according to clinical practice guideline recommendations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They agree to participate in the study by signing an informed consent form\n\nExclusion Criteria:\n\n* Decline to participate in the study\n* Patients living 6 months or less in the reference health area\n* Patients with active malignant tumors'}, 'identificationModule': {'nctId': 'NCT05600218', 'acronym': 'RAMPHA', 'briefTitle': 'RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Costa del Sol'}, 'officialTitle': 'Real World Andalusian Multicenter Data on Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists', 'orgStudyIdInfo': {'id': '0991-N-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients with pulmonary arterial hypertension on treatment with prostacyclin IP receptor agonists because they are at intermediate risk of mortality at one year', 'interventionNames': ['Drug: No intervention - Observational study']}], 'interventions': [{'name': 'No intervention - Observational study', 'type': 'DRUG', 'description': 'Real life drug evaluation', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'El Ejido', 'state': 'Almería', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joaquín Vizcaíno Ricoma', 'role': 'CONTACT'}, {'name': 'Joaquín Vizcaíno Ricoma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Poniente', 'geoPoint': {'lat': 36.77629, 'lon': -2.81456}}, {'city': 'Úbeda', 'state': 'Jaén', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Bonilla Palomas Bonilla Palomas', 'role': 'CONTACT'}, {'name': 'Juan Luis Bonilla Palomas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital San Juan de la Cruz', 'geoPoint': {'lat': 38.01328, 'lon': -3.3705}}, {'city': 'Marbella', 'state': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Bravo Marques', 'role': 'CONTACT'}, {'name': 'Rafael Bravo Marques', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Luis Calleja Rubio', 'role': 'CONTACT'}, {'name': 'Juan Luis Calleja Rubio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinico Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Morgado García de Polavieja', 'role': 'CONTACT'}, {'name': 'José Morgado García de Polavieja', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ignacio Martín Suárez', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Espíldora Hernández', 'role': 'CONTACT'}, {'name': 'Francisco Espíldora Hernández', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Regional de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Víctor Becerra Muñoz', 'role': 'CONTACT'}, {'name': 'Víctor Manuel Becerra Muñoz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene María Estrada Parra', 'role': 'CONTACT'}, {'name': 'Irene María Estrada Parra', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Amadeo Wals Rodríguez', 'role': 'CONTACT'}, {'name': 'Amadeo Wals Rodríguez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alejandro Recio Mayoral', 'role': 'CONTACT'}, {'name': 'Alejandro Recio Mayoral', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Rafael Bravo Marqués, PhD, MD', 'role': 'CONTACT', 'email': 'rafabravomarques@gmail.com', 'phone': '034 686202746'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Once the database has been completed and the main results article has been published, access to the database through a free repository (e.g. Mendeley) will be considered.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Costa del Sol', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, {'name': 'Hospital Regional de Malaga', 'class': 'OTHER'}, {'name': 'Hospital Universitario Virgen de la Victoria', 'class': 'OTHER'}, {'name': 'Hospital San Juan de la Cruz', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario de Especialidades Juan Ramón Jimenez', 'class': 'OTHER'}, {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Hospital Clinico Universitario San Cecilio', 'class': 'OTHER'}, {'name': 'Hospital Universitario de Valme', 'class': 'OTHER'}, {'name': 'Hospital de Poniente', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Specialist, Department of Cardiology, Hospital Costa del Sol, Marbella (Malaga,) Spain', 'investigatorFullName': 'Rafael Bravo Marqués', 'investigatorAffiliation': 'Hospital Costa del Sol'}}}}