Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-02 @ 12:29 AM
Study NCT ID:
NCT04554069
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2020-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Antihypertensive Treatment on Serum Uric Acid in Newly Diagnosed Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2020-09-05', 'studyFirstSubmitQcDate': '2020-09-13', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension.', 'timeFrame': '6 months from baseline', 'description': 'we will measure the change of the level of serum uric acid after 6 months from the treatment of antihypertensive durgs'}], 'secondaryOutcomes': [{'measure': 'obesity', 'timeFrame': '6 months from baseline', 'description': 'it will be measured by BMI (kg/m2)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '11116127', 'type': 'BACKGROUND', 'citation': 'Verdecchia P, Schillaci G, Reboldi G, Santeusanio F, Porcellati C, Brunetti P. Relation between serum uric acid and risk of cardiovascular disease in essential hypertension. The PIUMA study. Hypertension. 2000 Dec;36(6):1072-8. doi: 10.1161/01.hyp.36.6.1072.'}, {'pmid': '17024135', 'type': 'BACKGROUND', 'citation': 'Shankar A, Klein R, Klein BE, Nieto FJ. The association between serum uric acid level and long-term incidence of hypertension: Population-based cohort study. J Hum Hypertens. 2006 Dec;20(12):937-45. doi: 10.1038/sj.jhh.1002095. Epub 2006 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of the influence of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension patients.', 'detailedDescription': 'Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately.\n\nThiazide-type diuretics, angiotensin-converting enzyme (ACE) inhibitors and some of angiotensin-II receptor blockers (ARB) were reported to reduce renal excretion of urate and increased serum uric acid levels, Beta-blockers also elevate serum uric acid levels.\n\nHyperuricemia is a risk factor for cardiovascular diseases. Hyperuricemia was found to correlate with hypertension excluding the influence of other factors such as age and renal function. Furthermore, many studies found that hyperuricemia was independently associated with cardiovascular events in patients treated with antihypertensive drugs.\n\nIt is important to control serum uric acid levels in hypertensive patients treated with antihypertensive drugs in order to reduce the risk of gout and cardiovascular events. There is a gap in knowledge in studies showing the effect of antihypertensive drugs on serum uric acid in newly diagnosed hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and Female participants aged 30 years old and above will be invited to participate in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All newly diagnosed hypertensive patients aged 30 years old and above will be invited to participate in this study\n\nExclusion Criteria:\n\n1. Patients below 30 years old.\n2. Patients with kidney disease.\n3. Patients who are taking medications known to increase SUA as (Thiazide and Loop diuretics, Salicylates, Cyclosporin use) or decrease the level of uric acid in the urine as (Allopurinol, Febuoxstate).'}, 'identificationModule': {'nctId': 'NCT04554069', 'briefTitle': 'Effect of Different Antihypertensive Treatment on Serum Uric Acid in Newly Diagnosed Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Different Antihypertensive Treatment on Serum Uric Acid in Newly Diagnosed Hypertensive Patients', 'orgStudyIdInfo': {'id': 'Uric acid in Hypertension'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mentallah Abdelrahman, MBBCH', 'role': 'CONTACT', 'email': 'menahallah.osama@gmail.com', 'phone': '+201092772639'}], 'overallOfficials': [{'name': 'Dalia Mahran, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Public Health and Community Medicine', 'investigatorFullName': 'Dalia Mahran', 'investigatorAffiliation': 'Assiut University'}}}}