Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT03424993
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reflected Pulse Wave Amplitude', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.'}], 'secondaryOutcomes': [{'measure': 'Microvascular Function', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis'}, {'measure': 'Conduit Artery Endothelial Dependent Dilation', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'Brachial artery flow mediated dilation assessed by duplex ultrasound'}, {'measure': 'Arterial Stiffness', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'Carotid - Femoral pulse wave velocity assessed by applanation tonometry'}, {'measure': 'Forward pulse wave amplitude', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'Central hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endothelium, vascular', 'Cardiovascular Disease', 'Hemodynamics', 'Oxidative Stress', 'Dietary Sodium', 'Dietary Counseling'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure.', 'detailedDescription': 'Cardiovascular disease remains a major Public Health problem and is the leading cause of death in the US. Dietary sodium restriction is considered an important lifestyle modification for individuals with hypertension; however, there is controversy about the effects of dietary salt given that many individuals do not have "salt sensitive" blood pressure. Deleterious effects of salt on the vasculature may explain the finding that chronic DSR reduces the cardiovascular event rate by 25%despite only minor reductions in BP. It is not known whether dietary sodium restriction improves central pulsatile hemodynamics, known to be related to the development of left ventricular hypertrophy and heart failure risk, and whether the hypothesized improvements in central hemodynamics are similar in men \\& women. The purpose of this study is to determine the effects of dietary sodium restriction through dietary counseling on central hemodynamics and vascular function in men and women with salt resistant blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Habitual dietary sodium intake \\> 3400mg per day\n\nExclusion Criteria:\n\n* Abnormal resting ECG\n* Current abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count).\n* Hypertension (currently taking anti-hypertensive medications or resting blood pressure \\>140/90 mmHg)\n* Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease\n* Obesity (Body Mass Index \\> 30)\n* Current pregnancy\n* Unable to provide consent'}, 'identificationModule': {'nctId': 'NCT03424993', 'briefTitle': 'Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study', 'orgStudyIdInfo': {'id': '1083986'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary Sodium Restriction', 'description': 'Daily habitual dietary sodium intake \\< 2000mg', 'interventionNames': ['Other: Dietary Sodium Restriction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Routine habitual dietary sodium intake \\>3400mg', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Dietary Sodium Restriction', 'type': 'OTHER', 'description': 'A registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks', 'armGroupLabels': ['Dietary Sodium Restriction']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Participants will consume their routine habitual dietary sodium intake \\> 3400mg per day with regular pre determined check in phone calls from a registered dietician.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Department of Kinesiology and Applied Physiology, University of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'William B Farquhar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}, {'name': 'David G Edwards, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}, {'name': 'Shannon Lennon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'William Farquhar', 'investigatorAffiliation': 'University of Delaware'}}}}