Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 8:02 PM
Study NCT ID:
NCT05435703
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Cysts and Primary Aldosteronism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of any renal cyst finding to graded baseline renin concentration (mU/L)', 'timeFrame': 'Baseline', 'description': 'Number of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high'}], 'secondaryOutcomes': [{'measure': 'Correlation of renin concentration (mU/L) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)', 'timeFrame': 'During procedure', 'description': 'Renin concentration difference (mU/L)'}, {'measure': 'Correlation of renin activity (ng of Ang I/ml/h) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)', 'timeFrame': 'During procedure', 'description': 'Renin activity difference (ng of Ang I/ml/h)'}, {'measure': 'Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)', 'timeFrame': 'During procedure', 'description': 'Concentration difference (mU/l)'}, {'measure': 'Correlation of renin activity (ng of Ang I/ml/h) in right and left renal vein from the side with or without renal cysts (or other renal pathology)', 'timeFrame': 'During procedure', 'description': 'Activity difference (ng of Ang I/ml/h)'}, {'measure': 'Prevalence (%) of renal cysts in patients in computed tomography with contrast media', 'timeFrame': 'Baseline', 'description': 'Prevalence of cysts'}, {'measure': 'Association of prevalence of renal cysts (%) with severity of hypertension', 'timeFrame': 'Baseline', 'description': 'Percentage of patients with renal cysts when patients are grouped according to quartiles of severity of hypertension'}, {'measure': 'Association of prevalence of renal cysts (%) with duration (years) of hypertension', 'timeFrame': 'Baseline', 'description': 'Percentage of patients with renal cysts when patients are grouped according to quartiles of duration of hypertension (years)'}, {'measure': 'Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)', 'timeFrame': 'Baseline', 'description': 'Percentage of patients with renal cysts (%) when patients are grouped according to quartiles of lowest plasma potassium'}, {'measure': 'Association of prevalence of renal cysts (%) with severity of primary aldosteronism', 'timeFrame': 'Baseline', 'description': 'Percentage of patients with renal cysts when patients are grouped according to quartiles of aldosterone to renin ratio (pmol/L)/(mU/L)'}, {'measure': 'Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney', 'timeFrame': 'During procedure', 'description': 'Concentration difference'}, {'measure': 'Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts', 'timeFrame': 'During procedure', 'description': 'Concentration difference'}, {'measure': 'Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts', 'timeFrame': 'During procedure', 'description': 'Activity difference'}, {'measure': 'Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts', 'timeFrame': 'During procedure', 'description': 'Activity difference'}, {'measure': 'Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups', 'timeFrame': 'Baseline', 'description': 'Number of patients with renal cysts when renin concentration is low, low normal or high normal to high'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adrenal vein sampling', 'Renal cysts', 'Renin concentration', 'Renin activity'], 'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': 'During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analysed from these samples. Adrenal computed tomographies are analysed for cysts and other possible pathology by a blinded radiologist. Aim is to evaluate correlation between renal pathology and renin measurements.', 'detailedDescription': 'Aim of the study is to evaluate the prevalence of renal cysts and their association with renin concentrationand acitivity in samples from renal veins and inferior vena cava (IVC) in patients who undergo an adrenal vein sampling (AVS) because of primary aldosteronism.\n\nIn a prospective study up to 200 patients who have been referred to Tampere University Hospital for AVS are recruited during 24 months. Informed consent is taken. Clinical, medication, radiological and laboratory information according to Endcrine Society guidelines is collected. Interventional radiologist will draw venous blood from both renal veins and from IVC for later renin analyses. One, blinded radiologist will record renal pathology of cysts but also other abnormal radiologic features.\n\nAn interim analysis will be done when 60-100 patients have been recruited or at 6-12 months from the start of the study. Study will be stopped if significant difference can be found in renin measurement in patients with renal cysts compared with patients without renal cysts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed primary aldosteronism according to Endocrine Society guidelines\n* Adrenal vein sampling performed in Tampere University Hospital\n* Informed consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05435703', 'briefTitle': 'Renal Cysts and Primary Aldosteronism', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism', 'orgStudyIdInfo': {'id': 'R20023'}}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Pasi I Nevalainen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD may not be shareable according to local laws and regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}