Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT03560804
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
2015-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C437965', 'term': 'olmesartan'}, {'id': 'D002752', 'term': 'Chlorthalidone'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-15', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': '12 weeks', 'description': 'Measured by Sphygmocor devive'}], 'secondaryOutcomes': [{'measure': 'Systemic vascular resistance', 'timeFrame': '12 months', 'description': 'Measured by impendance cardiography'}, {'measure': 'Ambulatory blood pressure', 'timeFrame': '12 months', 'description': 'Daytime and nighttime systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['olmesartan', 'chlorthalidone', 'hemodynamics'], 'conditions': ['Arterial Stiffness', 'Ambulatory Blood Pressure Monitoring']}, 'descriptionModule': {'briefSummary': 'The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.\n\nThe drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.\n\nThe other basic aim of the study is to determine whether there is a difference (\\>6mmHg) between the two drugs regarding the reduction of the mean 24hour blood pressure and the effect of them on the hemodynamic parameters.\n\nThe hemodynamic parameters that will be measured by applanation tonometry are augmentation index, central blood pressure and pulse wave velocity.\n\nThe hemodynamic parameters that will be measured by impedance cardiography are cardiac index, thoracic fluid content index, systemic vascular resistance index and others.', 'detailedDescription': 'The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.\n\nThe drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Drug naive patients with 1st or 2nd grade Arterial Hypertension according to the ESH/ESC guidelines 2013\n* The patient has signed the concent form\n\nExclusion Criteria:\n\n* Secondary Hypertension\n* 3rd grade of Arterial Hypertension\n* Chronic renal failure\n* Diabetes Mellitus\n* Sleep apnea syndrome\n* Chronic or acute inflammatory diseases\n* Stroke, myocardial infarction, angina pectoris in the past 6 months\n* Heart failure\n* Liver disease\n* Neoplasms\n* Pregnancy\n* Valvular Heart disease\n* Heigt \\< 120cm or \\> 230cm, Weight \\<30kg or \\>155kg\n* Heart Arrhytmias\n* Artificial cardiac pacemaker\n* Hemodymanic unstable patients'}, 'identificationModule': {'nctId': 'NCT03560804', 'briefTitle': 'Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs', 'organization': {'class': 'OTHER', 'fullName': 'AHEPA University Hospital'}, 'officialTitle': 'Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.', 'orgStudyIdInfo': {'id': '100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Olmesartan', 'description': 'ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target', 'interventionNames': ['Drug: Olmesartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorthalidone', 'description': 'Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target', 'interventionNames': ['Drug: Chlorthalidone']}], 'interventions': [{'name': 'Olmesartan', 'type': 'DRUG', 'otherNames': ['Olartan'], 'description': 'Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.', 'armGroupLabels': ['Olmesartan']}, {'name': 'Chlorthalidone', 'type': 'DRUG', 'otherNames': ['Hygroton'], 'description': 'Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.', 'armGroupLabels': ['Chlorthalidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54635', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Hypertension Excellence Center, AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Zebekakis Pantelis, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHEPA University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-doctoral researcher', 'investigatorFullName': 'Maria Pikilidou, MD, MSc, PhD', 'investigatorAffiliation': 'AHEPA University Hospital'}}}}