Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT04690660
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss Postpartum Hypertension Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples for biomarker'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-27', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of persistent hypertension defined by 24 hours BP measurement', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Frequency of persistent hypertension defined by 24 hours BP measurement'}, {'measure': 'Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)'}, {'measure': 'Frequency of microalbuminuria', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Frequency of microalbuminuria'}, {'measure': 'Frequency of damage to the retina of the eyes (retinopathy)', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Frequency of damage to the retina of the eyes (retinopathy)'}, {'measure': 'Signs of hypertensive heart disease', 'timeFrame': 'up to 24 months', 'description': 'Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)'}, {'measure': 'Frequency of dyslipidemia', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Frequency of dyslipidemia'}, {'measure': 'Frequency of prediabetes/diabetes', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Frequency of prediabetes/diabetes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy Induced Hypertension (PIH)', 'Home Blood Pressure Monitoring (HBPM)', 'Office Blood Pressure Monitoring (OBPM)', 'Automated Office Blood Pressure Measurement (AOBPM)', 'Gestational Hypertension', 'HekaHealth Self-Measured Blood Pressure (SMBP) App'], 'conditions': ['Postpartum Hypertension (PPHT)']}, 'descriptionModule': {'briefSummary': 'This open label, prospective observational, single-center registry is to study short-, intermediate-and long-term course of postpartum hypertension and predictors/risk factors associated with long term cardiovascular and renal risk.\n\nCurrent disease management strategies will be evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will take place at the Hypertension Clinic of the Medical Outpatient Department at the University Hospital Basel and the Department of Obstetrics and Gynaecology at the University Hospital Basel. Participants will be consecutively screened and recruited by the treating physicians and the Hypertension Team of the Hypertension Clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all women with hypertensive disorders of pregnancy\n* postpartum hypertension (blood pressure measurements of systolic ≥140 and/or diastolic ≥ 90mmHg or antihypertensive therapy within the first 14 days after delivery)\n* women with preexisting hypertension or\n* women on antihypertensive medication\n\nExclusion Criteria:\n\n* delivery \\> 14 days\n* lack of consent to participate in the study, language barriers or lack of general understanding'}, 'identificationModule': {'nctId': 'NCT04690660', 'briefTitle': 'Swiss Postpartum Hypertension Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Swiss Postpartum Hypertension Cohort (Swiss-PPHT)', 'orgStudyIdInfo': {'id': '2020-00736; me20Burkard'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection for parameters of organ damage (cardiac and renal blood markers)', 'type': 'OTHER', 'description': 'Blood results will be taken out of next routine venipuncture. Routinely collected standard parameters are a blood count, chemistry panel including renal parameters and electrolytes, lipid profile and a HbA1c as well as albumin/creatinine and protein/creatinine ratio in urine.'}, {'name': 'Data collection for blood pressure (BP)', 'type': 'OTHER', 'description': 'Clinic blood pressure and 24hour BP Measurements'}, {'name': 'Home-based blood pressure management (substudy)', 'type': 'OTHER', 'description': 'Subjects participating in home-based blood pressure management via telemonitoring will receive a free HekaHealth application (App) for the structured assessment of HBPM.'}, {'name': 'Biomarker Profiles (substudy)', 'type': 'OTHER', 'description': 'Substudy where possible cardiac, renal and pregnancy related biomarkers will be additionally analyzed. The following biomarkers will be analyzed: N terminal (NT)-proBNP, Troponin, elevated mid-regional pro-atrial natriuretic peptide (ANP), elevated mid-regional pro adrenomedullin (ADM), soluble fms-like tyrosine kinase (sFlt-1), and placenta growth factor (PlGF).'}, {'name': 'Data collection on patient reported outcomes', 'type': 'OTHER', 'description': 'Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thenral Socrates, Dr. med.', 'role': 'CONTACT', 'email': 'thenral.socrates@usb.ch', 'phone': '+41 61 328 6647'}, {'name': 'Thenral Socrates, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Mayr, PD Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irene Hösli, Prof. Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olav Lapaire, Prof. Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical Outpatient Department and Hypertension Clinic, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Thenral Socrates, Dr. med.', 'role': 'CONTACT', 'email': 'thenral.socrates@usb.ch', 'phone': '+41 61 328 6647'}, {'name': 'Thilo Burkard, Dr. med.', 'role': 'CONTACT', 'email': 'thilo.burkard@usb.ch', 'phone': '+41 61 328 7738'}], 'overallOfficials': [{'name': 'Thenral Socrates, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Outpatient Department and Hypertension Clinic, University Hospital BaselUni'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}