Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT06022133
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Binding not possible as patients needs to carry out dietary sodium restriction themselves.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in nocturnal systolic blood pressure', 'timeFrame': 'from day 14 to day 28', 'description': 'Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)'}], 'secondaryOutcomes': [{'measure': 'Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)', 'timeFrame': 'from day 14 to day 28', 'description': 'Comparison of blood pressure measured by 24h blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)'}, {'measure': 'Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)', 'timeFrame': 'from day 14 to day 28', 'description': 'Comparison of apnoea hypopnoea index measured by cardio respiratory monitoring at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)'}, {'measure': 'Changes in day:night sodium urinary sodium excretion', 'timeFrame': 'from day 14 to day 28', 'description': 'Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)'}, {'measure': 'Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)', 'timeFrame': 'from day 14 to day 28', 'description': 'Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)'}, {'measure': 'Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)', 'timeFrame': 'from day 14 to day 28', 'description': 'Comparison of biomarkers from blood samples drawn at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sodium Imbalance', 'Nocturnal Blood Pressure', 'Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '37726656', 'type': 'DERIVED', 'citation': 'Hornstrup BG, Hoffmann-Petersen N, Lauridsen TG, Bech JN. Dietary sodium restriction reduces blood pressure in patients with treatment resistant hypertension. BMC Nephrol. 2023 Sep 19;24(1):274. doi: 10.1186/s12882-023-03333-9.'}]}, 'descriptionModule': {'briefSummary': 'A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.', 'detailedDescription': 'A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Patients with hypertension resistant of antihypertensive treatment have a high frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal pauses in breathing in this patients population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 24h blood pressure \\> 130/80 mmHg under antihypertensive treatment with three agent, one of these being diuretic. Blood pressure measurement completed after observed intake of antihypertensive medication.\n* unchanged antihypertensive treatment for three months\n* estimated glomerular function \\>45 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* Heart failure assessed from NYHA classification (grade 3-4)\n* Presence of clinically significant peripheral edema\n* In treatment for obstructive sleep apnea\n* Chronic obstructive pulmonary disease (FEV1 \\<50%)\n* Antihypertensive therapy that can not be taken once daily\n* Pregnancy or breastfeeding\n* Β-albumin \\<34 g / l\n* U-albumin creatinine ratio\\> 1000 mg / g\n* INR\\> 1.2 (if marevan treatment: ALAT\\> 200)\n* Gluten allergy (dietary guidelines are not adjusted to this group)'}, 'identificationModule': {'nctId': 'NCT06022133', 'acronym': 'ROSA', 'briefTitle': 'Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing', 'orgStudyIdInfo': {'id': 'BGH-5-2017'}, 'secondaryIdInfos': [{'id': '1-10-72-253-17', 'type': 'OTHER', 'domain': 'The Scientific Ethical Committees for Central Denmark Region'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary sodium restriction', 'description': 'DIetary sodium restriction', 'interventionNames': ['Behavioral: Dietary sodium restriction']}, {'type': 'NO_INTERVENTION', 'label': 'Usual diet', 'description': 'Usual diet'}], 'interventions': [{'name': 'Dietary sodium restriction', 'type': 'BEHAVIORAL', 'description': 'Selfemployed dietary sodium restriction', 'armGroupLabels': ['Dietary sodium restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Gødstrup', 'state': 'Herning', 'country': 'Denmark', 'facility': 'University clinic in Nephrology and hypertension, Regional Hospital Godstrup', 'geoPoint': {'lat': 56.15584, 'lon': 8.89276}}, {'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Department of Medical Research and Medicine, Holstebro Regional Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Bodil Hornstrup', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D., Ph.D.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jesper Norgaard Bech', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD, head of University Clinic in Nephrology and Hypertension, Regeional Hospital Vest Justland and Aarhus university', 'investigatorFullName': 'Jesper Norgaard Bech', 'investigatorAffiliation': 'Regional Hospital Holstebro'}}}}