Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01278732
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2011-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-31', 'studyFirstSubmitDate': '2011-01-18', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular mass (m-mode echocardiography)', 'timeFrame': 'measured within 4 weeks from ABPM'}], 'secondaryOutcomes': [{'measure': 'urine albumine / creatinine ratio', 'timeFrame': 'measured within 2 weeks from ABPM but before antihypertensive treatment is started'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arterial hypertension'], 'conditions': ['Suspected Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '29061725', 'type': 'DERIVED', 'citation': 'Weber T, Wassertheurer S, Schmidt-Trucksass A, Rodilla E, Ablasser C, Jankowski P, Lorenza Muiesan M, Giannattasio C, Mang C, Wilkinson I, Kellermair J, Hametner B, Pascual JM, Zweiker R, Czarnecka D, Paini A, Salvetti M, Maloberti A, McEniery C. Relationship Between 24-Hour Ambulatory Central Systolic Blood Pressure and Left Ventricular Mass: A Prospective Multicenter Study. Hypertension. 2017 Dec;70(6):1157-1164. doi: 10.1161/HYPERTENSIONAHA.117.09917. Epub 2017 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate whether central systolic blood pressure, as measured during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of left ventricular mass than peripheral systolic blood pressure during ABPM.', 'detailedDescription': 'It seems obvious that central blood pressures are pathophysiologically more relevant than peripheral blood pressures for the pathogenesis of cardiovascular disease: it is central systolic pressure (cSBP) against the heart ejects (afterload), and it is central pulse pressure (cPP) that distends the large elastic arteries. Indeed, cSBP and cPP have been associated more closely with left ventricular hypertrophy and carotid atherosclerosis as markers of hypertensive end-organ damage than brachial pressures in various populations. However, in these studies office blood pressure measurements have been used. As ABPM measurements per se show a closer association with hypertensive end-organ damage than office measurements, and as the investigators have recently developed and validated a novel algorithm (ARCSolver) to calculate central blood pressures from peripheral waveforms, the investigators speculate that cSBP measured during ABPM may be the best predictor of left ventricular mass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\> 18 years of age,\n\n* no intake of antihypertensive medications\n* should have an indication for ABPM (suspected arterial hypertension)\n\nExclusion Criteria:\n\n* no written informed consent\n* left ventricular hypertrophy due to other reasons than hypertension (hypertrophic cardiomyopathy, infiltrative cardiomyopathy, valvular heart disease, congenital heart disease)\n* inability to provide adequate echocardiographic readings\n* segmental contraction abnormalities of the left ventricle\n* contraindications for ABPM (lymphedema both arms)\n* other rhythm than stable sinus rhythm\n* unstable clinical condition, including recent severe infections'}, 'identificationModule': {'nctId': 'NCT01278732', 'briefTitle': 'Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Wels-Grieskirchen'}, 'officialTitle': 'Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mas', 'orgStudyIdInfo': {'id': 'EK D-4-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'untreated persons with suspected hypertension', 'interventionNames': ['Other: no intervention performed']}], 'interventions': [{'name': 'no intervention performed', 'type': 'OTHER', 'description': 'no intervention is performed', 'armGroupLabels': ['untreated persons with suspected hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Wels', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Cardiology Department, Klinikum Wels-Grieskirchen', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'city': 'Graz', 'country': 'Austria', 'facility': 'Cardiology Department, University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Cardiology Department, University of Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Sotiria Hospital 3rd Department of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Department of Medical and Surgical Sciences, University of Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Monza', 'country': 'Italy', 'facility': 'Clinica Medica, Hospitalo San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': 'E - 46520', 'city': 'Port de Sagunt', 'country': 'Spain', 'facility': 'Hospital de Sagunto', 'geoPoint': {'lat': 39.6622, 'lon': -0.21749}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Clinical pharmacology unit, University of Cambridge', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Thomas Weber, MD, associate professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Department, Klinikum Wels-Grieskirchen, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Wels-Grieskirchen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Austrian Society of Hypertension', 'class': 'UNKNOWN'}, {'name': 'European Regional Development Fund', 'class': 'OTHER'}, {'name': 'I.E.M. (Stolberg, Germany)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Thomas Weber', 'investigatorFullName': 'Thomas Weber', 'investigatorAffiliation': 'Klinikum Wels-Grieskirchen'}}}}