Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-04-21 @ 10:48 PM
Study NCT ID:
NCT02298556
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in systolic blood pressure', 'timeFrame': 'from baseline to week 8', 'description': 'mmHg'}], 'secondaryOutcomes': [{'measure': 'Absolute change in diastolic blood pressure (DBP)', 'timeFrame': 'from baseline to week 8', 'description': 'mmHg'}, {'measure': 'Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg', 'timeFrame': 'from baseline to week 8'}, {'measure': 'Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)', 'timeFrame': 'from baseline to week 8'}, {'measure': 'Absolute change of heart rate', 'timeFrame': 'from baseline to week 8', 'description': 'beat/min'}, {'measure': 'Correlation between absolute change in blood pressure and absolute change in heart rate', 'timeFrame': 'from baseline to week 8'}, {'measure': 'The absolute change in PR interval on electrocardiography', 'timeFrame': 'from baseline to week 8', 'description': 'ms. The PR interval indicates "atrioventricular conduction time".'}, {'measure': 'The absolute change in HbA1c (if available)', 'timeFrame': 'from baseline to week 8'}, {'measure': 'The absolute change in microalbuminuria (if available)', 'timeFrame': 'from baseline to week 8', 'description': 'mg/mmol'}, {'measure': 'The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event', 'timeFrame': 'from baseline to week 8'}, {'measure': "The correlation between physician's office and home blood pressure measurements (Difference in medians)", 'timeFrame': 'from baseline to week 8', 'description': 'mmHg'}, {'measure': 'Blood pressure variability (daily or hourly) in home blood pressure measurement', 'timeFrame': 'from baseline to week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes Mellitus', 'ACE Inhibitors', 'Calcium Channel Blockers'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '32964020', 'type': 'DERIVED', 'citation': 'Atalar E, Eskin F, Tugtekin HB, Karabulut A, Kanyilmaz S, Kirbiyik H, Ozyildiz AG. A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study. Biomed Res Int. 2020 Sep 5;2020:2123601. doi: 10.1155/2020/2123601. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'State Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* ≥ 18 years old\n* Has been already diagnosed with hypertension\n* Has been already diagnosed with type 2 diabetes mellitus\n* Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment\n* Heart rate ≥70 beat per minute\n\nExclusion Criteria:\n\n* Pregnant or breast feeding female\n* Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination\n* Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker;\n* Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination\n* Is currently participating in another clinical or non-clinical study'}, 'identificationModule': {'nctId': 'NCT02298556', 'acronym': 'HARVEST-TR', 'briefTitle': 'An Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Prospective Noninterventional, Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Non-dihydropyridine Calcium Channel Blocker Single Pill Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GSS-13-0019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive patients', 'description': 'Hypertensive patients with elevated heart rate and type 2 diabetes mellitus'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001108', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001030', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '6170', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Yıldırım Beyazıt University Yenimahalle Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '07059', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001111', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '09020', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001120', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001119', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'zip': '10000', 'city': 'Balıkesir', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001116', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}, {'zip': '15300', 'city': 'Burdur', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001112', 'geoPoint': {'lat': 37.72028, 'lon': 30.29083}}, {'zip': '19200', 'city': 'Çorum', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001123', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}, {'zip': '25040', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Erzurum Regional Training and Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}, {'zip': '25080', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Aziziye Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}, {'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001118', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34147', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001117', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34668', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34920', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001125', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '78100', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001113', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}, {'zip': '42250', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001110', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'zip': '71400', 'city': 'Kırıkkale', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001115', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}, {'zip': '61800', 'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001122', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}, {'zip': '34662', 'city': 'Üsküdar', 'country': 'Turkey (Türkiye)', 'facility': 'Uskudar PublicHospital', 'geoPoint': {'lat': 41.02274, 'lon': 29.01366}}, {'zip': '77000', 'city': 'Yalova', 'country': 'Turkey (Türkiye)', 'facility': 'Yalova Public Hospital', 'geoPoint': {'lat': 40.65501, 'lon': 29.27693}}, {'zip': '67900', 'city': 'Zonguldak', 'country': 'Turkey (Türkiye)', 'facility': 'Research facility ID ORG-001124', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}], 'overallOfficials': [{'name': 'Enver Atalar, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University Faculty of Medicine Hospital Cardiology Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MonitorCRO', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}