Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT05636995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2022-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HyperAldosteronism in Pregnancy Predicted Impacts (H.A.P.P.I. Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}, {'id': 'D014115', 'term': 'Toxemia'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary hyperaldosteronism (PHA) prevalence in pregnant women with hypertensive disorders of pregnancy.', 'timeFrame': 'Screening done between 4 and 24 weeks post-partum', 'description': 'Prevalence of PHA in women with a hypertensive disorder of pregnancy in last pregnancy'}], 'secondaryOutcomes': [{'measure': 'Maternal and fetal impacts of PHA on hypertensive disorders of pregnancy', 'timeFrame': 'During last pregnancy and 6 weeks postpartum', 'description': 'Comparison of the prevalence of each pre-specified complications (obstetrical, maternal, fetal, neonatal) between the PHA group and the non-PHA group.'}, {'measure': 'Prevalence of PHA for each hypertensive disorder of pregnancy', 'timeFrame': 'During last pregnancy and 6 weeks postpartum', 'description': 'Comparison of the prevalence of each HDP subtype (i.e. chronic hypertension, gestational hypertension, pre-eclampsia)'}, {'measure': 'Impact of the timing of PHA on hypertensive disorders of pregnancy', 'timeFrame': 'During last pregnancy and 6 weeks postpartum', 'description': 'Comparison between pregnancy outcomes for PHA diagnosed before the pregnancy with those diagnosed in post-partum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy Outcome', 'Prevalence'], 'conditions': ['Primary Hyperaldosteronism', 'Hypertensive Disorder of Pregnancy']}, 'referencesModule': {'references': [{'pmid': '33393127', 'type': 'BACKGROUND', 'citation': 'Alam S, Kandasamy D, Goyal A, Vishnubhatla S, Singh S, Karthikeyan G, Khadgawat R. High prevalence and a long delay in the diagnosis of primary aldosteronism among patients with young-onset hypertension. Clin Endocrinol (Oxf). 2021 Jun;94(6):895-903. doi: 10.1111/cen.14409. Epub 2021 Feb 22.'}, {'pmid': '24927294', 'type': 'BACKGROUND', 'citation': 'Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy: executive summary. J Obstet Gynaecol Can. 2014 May;36(5):416-41. doi: 10.1016/s1701-2163(15)30588-0. English, French.'}, {'pmid': '28554307', 'type': 'BACKGROUND', 'citation': 'Turner K, Hameed AB. Hypertensive Disorders in Pregnancy Current Practice Review. Curr Hypertens Rev. 2017;13(2):80-88. doi: 10.2174/1573402113666170529110024.'}, {'pmid': '27682655', 'type': 'BACKGROUND', 'citation': 'Umesawa M, Kobashi G. Epidemiology of hypertensive disorders in pregnancy: prevalence, risk factors, predictors and prognosis. Hypertens Res. 2017 Mar;40(3):213-220. doi: 10.1038/hr.2016.126. Epub 2016 Sep 29.'}, {'pmid': '27156905', 'type': 'BACKGROUND', 'citation': 'Landau E, Amar L. Primary aldosteronism and pregnancy. Ann Endocrinol (Paris). 2016 Jun;77(2):148-60. doi: 10.1016/j.ando.2016.04.009. Epub 2016 May 6.'}, {'pmid': '35569086', 'type': 'BACKGROUND', 'citation': 'Downie E, Shanmugalingam R, Hennessy A, Makris A. Assessment and Management of Primary Aldosteronism in Pregnancy: A Case-Control Study. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3152-e3158. doi: 10.1210/clinem/dgac311.'}, {'pmid': '19171690', 'type': 'BACKGROUND', 'citation': 'Escher G. Hyperaldosteronism in pregnancy. Ther Adv Cardiovasc Dis. 2009 Apr;3(2):123-32. doi: 10.1177/1753944708100180. Epub 2009 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'Primary hyperaldosteronism confers a higher risk of cardiovascular complications compared to essential hypertension. Preliminary data is controversial in regards of excessive maternal fetal and neonatal excessive risks in pregnancy.\n\nThis study aims at establishing the prevalence of PHA in an population with a recent episode of hypertensive disorder of pregnancy (HDP). The goal is to determine if a universal screening for PHA after a HDP is worthed. The investigators also wish to evaluate the complication rate in pregnant women with PHA compared to women without PHA.\n\nThis is a prospective cohort study where all eligible women will be screened for PHA after a HDP episode in the last pregnancy. We will then compare PHA women to non PHA women according to pregnancy complications.', 'detailedDescription': "This is a pilot study to evaluate feasibility and proof of concept. This is a prospective multicenter cohort study. Two university centers will participate (Sherbrooke and Montreal).\n\nParticipants will be recruited from post-partum Obstetric Medicine clinic in two tertiary care centers. They will be included if they presented a hypertensive disorder of preganncy (HDP) in their last pregnacy (from 4 weeks to 24 months after delivery). Women with pheochromocytoma, Cushing syndrome, secondary hyperaldosteronism, and those who are currently pregnant will be excluded.\n\nAll participants will be screened for PHA (with an aldosterone/renin ratio) and if the screening test is positive, they will be referred to a specialist to confirm the diagnosis.\n\nData will be collected from the participants and their babies' charts. Demographic data, obstetrical data, delivery data, maternal/fetal/neonatal complications, and diagnostic of PHA data will be collected.\n\nA convenient sample size of 200 women will be used. If the prevalence of HPA is 5% or more, this would justify a larger study.\n\nPrimary outcome: establish the prevalence of PHA in women with a hypertensive disorders of pregnancy in last pregancy.\n\nSecondary outcome include:\n\n1. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) and pregnant women without PHA.\n2. to establish the prevalence of PHA for each sub-type of hypertensive disorder of pregnancy\n3. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) before pregnancy and pregnant women diagnosed with PHA after pregnancy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post-partum women who are followed in a specialized post-partum clinic in Montreal or Sherbrooke (Qc, Canada) for their hypertensive disorder during their latest pregnancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 4 and 24 weeks post-partum women who had a hypertensive disorder during their latest pregnancy.\n\nExclusion Criteria:\n\n* Ongoing pregnancy\n* Diagnosed pheochromocytoma\n* Diagnosed Cushing syndrome\n* Diagnosed secondary hyperaldosteronism'}, 'identificationModule': {'nctId': 'NCT05636995', 'briefTitle': 'HyperAldosteronism in Pregnancy Predicted Impacts (H.A.P.P.I. Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'HyperAldosteronism in Pregnancy Predicted Impacts', 'orgStudyIdInfo': {'id': 'MP-31-2023-4857'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Hyperaldosteronism Diagnosed Women', 'description': 'Post-partum women who had a hypertensive disorder of pregnancy and a screened primary hyperaldosteronism (positive aldosterone/renin ratio).', 'interventionNames': ['Diagnostic Test: Aldosterone/Renin Ratio']}, {'label': 'Control Women', 'description': 'Post-partum women who had a hypertensive disorder of pregnancy without underlying primary hyperaldosteronism (negative aldosterone/renin ratio)', 'interventionNames': ['Diagnostic Test: Aldosterone/Renin Ratio']}], 'interventions': [{'name': 'Aldosterone/Renin Ratio', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.', 'armGroupLabels': ['Control Women', 'Primary Hyperaldosteronism Diagnosed Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hopitalier Universiatire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Nadine Sauvé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nadine Sauvé', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}