Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-04-14 @ 9:52 PM
Study NCT ID:
NCT05918458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discovering Clinical Study Experiences of Patients With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-15', 'size': 88479, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-15T08:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-23', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who decide to enroll in a pulmonary hypertension clinical research', 'timeFrame': '3 months'}, {'measure': 'Rate of patients who remain in pulmonary hypertension clinical research to trial completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '35926542', 'type': 'BACKGROUND', 'citation': 'Jais X, Brenot P, Bouvaist H, Jevnikar M, Canuet M, Chabanne C, Chaouat A, Cottin V, De Groote P, Favrolt N, Horeau-Langlard D, Magro P, Savale L, Prevot G, Renard S, Sitbon O, Parent F, Tresorier R, Tromeur C, Piedvache C, Grimaldi L, Fadel E, Montani D, Humbert M, Simonneau G. Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study. Lancet Respir Med. 2022 Oct;10(10):961-971. doi: 10.1016/S2213-2600(22)00214-4. Epub 2022 Aug 1.'}, {'pmid': '28025931', 'type': 'BACKGROUND', 'citation': 'Divers C, Platt D, Wang E, Lin J, Lingohr-Smith M, Mathai SC. A Review of Clinical Trial Endpoints of Patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension and How They Relate to Patient Outcomes in the United States. J Manag Care Spec Pharm. 2017 Jan;23(1):92-104. doi: 10.18553/jmcp.2017.23.1.92.'}, {'pmid': '32657833', 'type': 'BACKGROUND', 'citation': 'Harder EM, Waxman AB. Clinical trials in group 3 pulmonary hypertension. Curr Opin Pulm Med. 2020 Sep;26(5):391-396. doi: 10.1097/MCP.0000000000000694.'}]}, 'descriptionModule': {'briefSummary': "Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.\n\nThis study will admit a wide range of data on the clinical trial experience of pulmonary hypertension patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary hypertension patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pulmonary hypertension who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n* Diagnosis of pulmonary hypertension\n\nExclusion Criteria:\n\n* No diagnosis of pulmonary hypertension confirmed\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form'}, 'identificationModule': {'nctId': 'NCT05918458', 'briefTitle': 'Discovering Clinical Study Experiences of Patients With Pulmonary Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Pulmonary Hypertension Clinical Trials: What Are Prevailing Patient Experiences in Pulmonary Hypertension Studies', 'orgStudyIdInfo': {'id': '82814554'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '415-900-4227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}