Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT06416735
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000584', 'term': 'Amiloride'}], 'ancestors': [{'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate urinary sodium', 'timeFrame': '3 hrs and 6 hrs', 'description': 'Evaluation of sodium levels after oral administration of Amiloride'}], 'secondaryOutcomes': [{'measure': 'Evaluate potassium levels', 'timeFrame': '3 hrs and 6 hrs', 'description': 'Evaluation of potassium plasma levels after oral administration of Amiloride'}, {'measure': 'Evaluation of systolic blood pressure', 'timeFrame': '3 hrs and 6 hrs', 'description': 'Evaluation of systolic blood pressure after oral administration of Amiloride'}, {'measure': 'Evaluation of diastolic blood pressure', 'timeFrame': '3 hrs and 6 hrs', 'description': 'Evaluation of diastolic blood pressure after oral administration of Amiloride'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Salt'], 'conditions': ['Hypertension Essential', 'Salt Excess', 'Genetic Hypertension']}, 'descriptionModule': {'briefSummary': 'The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.', 'detailedDescription': "The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male patients aged 18-60 years;\n* naïve hypertensive patients: newly diagnosed, never previously treated for hypertension;\n* BMI\\<30 Kg/m2,\n* documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be \\>=140 mmHg or diastolic BP \\>=90 mmHg;\n* signature of the informed consent for participation in the study\n* patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).\n\nExclusion Criteria:\n\nknown causes of secondary hypertension;\n\n* severe or malignant hypertension; history of renal artery disease;\n* significant renal disease (creatinine clearance less than 60 ml/min);\n* hyperkalemia (Kpl \\> 6mEq/l) at enrollment visit;\n* hypercalcaemia (Ca pl \\> 2.6 mmol/l) at enrollment visit;\n* symptomatic hyperuricemia (\\> 7.5 mg/dl);\n* liver disease (transaminases greater than 3 times the normal value);\n* cardiac pathologies (myocardial infarction, atrial fibrillation, etc.);\n* diabetes (fasting blood sugar \\>125mg/dl);\n* in therapy with statins, NSAIDs, systemic steroids;\n* known hypersensitivity to Amiloride or to any of the excipients;\n* patients unable to express a valid consent -'}, 'identificationModule': {'nctId': 'NCT06416735', 'acronym': 'ADD-AMI', 'briefTitle': 'Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Natriruetic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant', 'orgStudyIdInfo': {'id': 'ADD-AMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients carrying the wild-type (GG) genotype of ADD1 rs4961', 'description': 'The protocol involves a test of oral administration of a single dose of Amiloride (5 or 10 mg based on body weight) to 20 patients carrying the wild-type (GG) genotype of ADD1 rs4961', 'interventionNames': ['Drug: Amiloride']}, {'type': 'EXPERIMENTAL', 'label': 'patients carriers of variant T (GT or TT)', 'description': 'The test involves the administration of a single dose of 5 or 10 mg of Amiloride to 20 hypertensive carriers of the T variant (GT or TT)', 'interventionNames': ['Drug: Amiloride']}], 'interventions': [{'name': 'Amiloride', 'type': 'DRUG', 'description': 'administration of a single dose of 5 or 10 mg of Amiloride (based on body weight) After oral intake of the drug, the increase in sodium in the urine ends within 8 hours', 'armGroupLabels': ['patients carriers of variant T (GT or TT)', 'patients carrying the wild-type (GG) genotype of ADD1 rs4961']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor in nephrology unit, nephrologist', 'investigatorFullName': 'Chiara Lanzani', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}