Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT04625569
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2020-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic of Response to Acute Saline Load Test in Hypertension (Naload)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and urinary sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DMBP120', 'timeFrame': '120 min', 'description': 'Blood pressure variation at the end of infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'salt sensitivity', 'genetic'], 'conditions': ['Hypertension,Essential', 'Salt; Excess', 'Genetic Hypertension', 'Genetic Predisposition to Disease']}, 'referencesModule': {'references': [{'pmid': '24185693', 'type': 'BACKGROUND', 'citation': "Trudu M, Janas S, Lanzani C, Debaix H, Schaeffer C, Ikehata M, Citterio L, Demaretz S, Trevisani F, Ristagno G, Glaudemans B, Laghmani K, Dell'Antonio G; SKIPOGH team; Loffing J, Rastaldi MP, Manunta P, Devuyst O, Rampoldi L. Common noncoding UMOD gene variants induce salt-sensitive hypertension and kidney damage by increasing uromodulin expression. Nat Med. 2013 Dec;19(12):1655-60. doi: 10.1038/nm.3384. Epub 2013 Nov 3."}, {'pmid': '31992575', 'type': 'BACKGROUND', 'citation': 'Citterio L, Delli Carpini S, Lupoli S, Brioni E, Simonini M, Fontana S, Zagato L, Messaggio E, Barlassina C, Cusi D, Manunta P, Lanzani C. Klotho Gene in Human Salt-Sensitive Hypertension. Clin J Am Soc Nephrol. 2020 Mar 6;15(3):375-383. doi: 10.2215/CJN.08620719. Epub 2020 Jan 28.'}, {'pmid': '26667413', 'type': 'BACKGROUND', 'citation': 'Lanzani C, Gatti G, Citterio L, Messaggio E, Delli Carpini S, Simonini M, Casamassima N, Zagato L, Brioni E, Hamlyn JM, Manunta P. Lanosterol Synthase Gene Polymorphisms and Changes in Endogenous Ouabain in the Response to Low Sodium Intake. Hypertension. 2016 Feb;67(2):342-8. doi: 10.1161/HYPERTENSIONAHA.115.06415. Epub 2015 Dec 14.'}, {'pmid': '24060892', 'type': 'BACKGROUND', 'citation': "Citterio L, Ferrandi M, Delli Carpini S, Simonini M, Kuznetsova T, Molinari I, Dell' Antonio G, Lanzani C, Merlino L, Brioni E, Staessen JA, Bianchi G, Manunta P. cGMP-dependent protein kinase 1 polymorphisms underlie renal sodium handling impairment. Hypertension. 2013 Dec;62(6):1027-33. doi: 10.1161/HYPERTENSIONAHA.113.01628. Epub 2013 Sep 23."}]}, 'descriptionModule': {'briefSummary': 'NHP referred to our outpatient clinic will be enrolled (150 newly recruited) in acute saline test for phenotype characterisation of PNat relationship(7). For each patient we will collect urine and blood samples for standard clinical biochemistry, including electrolytes, creatinine, EO, aldosterone, plasma renin activity, urinary uromodulin (ELISA), urinary and serum uric acid and blood samples for genetic test.', 'detailedDescription': 'Acute salt load test: after the equilibration period and achievement of a steady state, a constant-rate i.v. infusion of 2 L of 0.9% NaCl was carried out in 2 hours. BP (mean of 3 measurements taken 3 minutes apart) was measured every 30 minutes during the 2 hours of loading and 3 times at 3-min intervals at the end of the infusion. These last 3 BP values were averaged and used in the analysis.\n\nThe results of these tests will be added to an already collected database of salt load test collected in the previous studies (already published)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "We enrolled newly discovered, never treated, mild hypertensive male patients in the 'Outpatient Clinic for Hypertension' of San Raffaele Hospital, Milan (Italy)", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 65years;\n* body mass index (BMI) \\<30 kg/m2;\n* Na intake, evaluated as urinary Na excretion of \\<300 mEq/24 hours; .office systolic BP (SBP) \\>140 mm Hg and diastolic BP (DBP) \\>90 mm Hg in 3 consecutive visits to their family doctors.\n\nExclusion criteria:\n\n* Female patients\n* history of myocardial infarction,\n* stroke,\n* congestive heart failure,\n* liver disease, secondary cause of hypertension,\n* diabetes,\n* severe hypertension (\\>160/110 mm Hg),\n* abuse of drugs or alcohol, .creatinine clearance \\< 80 mL/m.\n\nSecondary forms of hypertension (e.g. primary aldosteronism) were ruled out with specific investigations when deemed appropriate'}, 'identificationModule': {'nctId': 'NCT04625569', 'acronym': 'Naload', 'briefTitle': 'Genetic of Response to Acute Saline Load Test in Hypertension (Naload)', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Role of Genetic Determinants in the Response to Acute Saline Load Testing in Patients With Essential Hypertension (Naload)', 'orgStudyIdInfo': {'id': 'Naload'}}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Lanzani, MD', 'role': 'CONTACT', 'email': 'lanzani.chiara@hsr.it', 'phone': '+390226433891'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Chiara Lanzani, doctor', 'role': 'CONTACT', 'email': 'lanzani.chiara@hsr.it', 'phone': '0206433891'}, {'name': 'Cinzia Scotti, secretary', 'role': 'CONTACT', 'email': 'scotti.cinzia@hsr.it', 'phone': '0226435330'}], 'overallOfficials': [{'name': 'Chiara Lanzani, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}