Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-25 @ 3:57 PM
Study NCT ID:
NCT05167968
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2021-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence of Diuretics in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2021-11-26', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR)', 'timeFrame': '2 weeks previous hospitalization', 'description': 'Prevalence of high adherence to diuretics in PH patients\n\nGirerd questionnaire is made up of 6 items which are evaluated in a binary way : Yes = 0 point \\& No = 1 point. Three medication categories are defined : high adherence (score = 6), moderate adherence (score = 4 or 5) and low adherence (score \\< or = 3). MPR is defined by the ratio between the number of days during which the patient is supplied for his medication and the number of days during he should be supplied his medication, over a given period (12 months). Patients with a MPR \\> 0,80 are considered to have a high adherence whereas patients with a MPR \\< 0,80 are considered to have a low adherence to diuretics.'}], 'secondaryOutcomes': [{'measure': 'To determine the determinants of non-adherence to diuretics', 'timeFrame': '12 months previous hospitalization', 'description': 'Determinants related to the patient, treatment, disease and care will be recorded.\n\nAssociation between selected determinants and adherence to diuretics will be analyzed'}, {'measure': 'To assess the risk of PH worsening occurrence in the non-adhesion group', 'timeFrame': '12 months previous hospitalization', 'description': 'Occurrence of serious events including non-programmed hospitalization for PH and/or worsening of the disease (15% reduction in the 6-minute walking test and worsening of the WHO functional class) and/or the need to reinforce specific within the 12 months preceding inclusion.\n\nComparison of serious event prevalence in the high- and low-adherence groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary hypertension', 'Right heart failure', 'Adherence diuretics'], 'conditions': ['Precapillary Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'In this prospective study, the investigators will implement a systematic assessment of adherence to diuretics in a cohort of patients with precapillary pulmonary hypertension.\n\nThis study is designed to:\n\n* determine the overall adherence rates for diuretic regimen\n* determine the determinants of non-adherence to diuretics\n* assess the risk of PH worsening occurrence in the non-adhesion group', 'detailedDescription': 'Introduction Precapillary pulmonary hypertension (PH) is characterized by remodeling of small pulmonary arteries leading to a progressive increase in pulmonary vascular resistance (PVR) resulting to right heart failure and ultimately death. The prognosis of PH is closely related to the ability of the right ventricle to adapt to the progressive increase in PVR. The occurrence of acute right ventricular decompensation is associated with a very poor prognosis at short term.\n\nThe management of precapillary PH is based on specific therapies combined with general measures and supportive therapies. Diuretic treatment is recommended in PAH patients with signs of RV failure and fluid retention (recommendation class I, level of evidence C). The beneficial effect of diuretics is probably essential for preventing episodes of acute right ventricular decompensation. However, no study analyzed the rate of adherence to diuretic regimen in PH patients and the impact of patterns of adherence to diuretics on the outcomes of patients.\n\nAim and objectives\n\nThe main objectives of this study are to:\n\n* determine the overall adherence rates for diuretic regimen\n* determine the determinants of non-adherence to diuretics\n* assess the risk of PH worsening occurrence in the non-adherence group\n\nMethodology\n\nEvaluation of subjects and adhesion to diuretics at inclusion are recorded:\n\n* Self-questioning of medication adherence: Girerd questionnaire\n* Assessment of the Medication Possession Ratio\n* Social and demographic data\n* Comorbidities\n* PH characteristics\n* Clinical evaluation: dyspnea assessed by NYHA functional class (New York Heart Association Functional Classification : I-IV), signs of right heart failure\n* Type of treatment regimen\n* History of serious events including non-programmed hospitalization for PH and/or worsening of the disease (15% reduction in the 6-minute walking test and worsening of the WHO functional class) and/or the need to reinforce specific PH therapies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Precapillary PH and diuretics treatment for at least 12 months, at least 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over 18 years old\n* Precapillary PH\n* Diuretics treatment for at least 12 months\n* Having given his/her non-opposition to participate\n\nExclusion Criteria:\n\n* Treatment regimen without diuretics\n* Diuretics treatment for less than 12 months\n* Postcapillary PH\n* People refusing or unable to give informed consent\n* No affiliation to a regime of social security.\n* Protected patients'}, 'identificationModule': {'nctId': 'NCT05167968', 'acronym': 'PHARE', 'briefTitle': 'Adherence of Diuretics in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '2021-A02137-34'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention (Observational cohort)', 'type': 'OTHER', 'description': 'For each patient, evaluation and adhesion to diuretics at inclusion are recorded:\n\n* Self-questioning of medication adherence: Girerd questionnaire\n* Assessment of the Medication Possession Ratio\n* Social and demographic data\n* Comorbidities\n* PH characteristics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hospital Bicêtre - Pneumology department', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Marie-Camille Chaumais, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bicêtre Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}