Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 4:55 AM
Study NCT ID:
NCT03648294
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000315', 'term': 'Adrenalectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adrenalectomy for primary hyperaldosteronism', 'timeFrame': '1 year', 'description': 'The objective of this study is to evaluate the course of the disease associated with long-term outcomes of adrenalectomy for the treatment of PAH, with a retrospective analysis of patient data!'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure'], 'conditions': ['Adrenalectomy; Status']}, 'descriptionModule': {'briefSummary': 'To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.\n\nExhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).', 'detailedDescription': 'To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Between 2002 and 2013, the investigators evaluated all patients receiving adrenalectomy and extracted data on PAH patients. The diagnosis was made on the presence of hypertension (all stages combined), an autonomous hyperproduction of aldosterone and sometimes hypokalemia (n = 32). HTA was defined, in accordance with the recommendations of the Haute Autorité de Santé and the French Society of Arterial Hypertension (blood pressure greater than or equal to 140/90 mmHg)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>25 years and \\<80 years patients undergoing adrenalectomy for PA\n* All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI).\n\nExclusion Criteria:\n\n* patients \\<25 years\n* patients \\> 80 years'}, 'identificationModule': {'nctId': 'NCT03648294', 'acronym': 'Hyperaldo', 'briefTitle': 'Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism', 'orgStudyIdInfo': {'id': 'PI2017_843_0040'}}, 'armsInterventionsModule': {'interventions': [{'name': 'adrenalectomy for primary addosteronism', 'type': 'OTHER', 'description': 'All of the clinical and biological data were retrospectively compiled from the patient computerized record. The variables analyzed were: age, sex, body mass index (BMI), PAH discovery circumstances, pre- and postoperative systolic and diastolic blood pressure assessments, number of pre-hypertensive antihypertensive drug - and postoperatively, the laterality, the size and nature of the lesions, the operating time, the surgical technique used. The biological data evaluated were pre- and postoperative plasma and plasma creatinine, preoperative serum aldosterone concentrations, plasma renin activity, and preoperative aldosterone / renin ratio. Hypokalemia was defined as serum concentration below 3.5 mmol / L.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fabien Saint, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU AMIENS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}