Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT01435161
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2011-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'D000959', 'term': 'Antihypertensive Agents'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-15', 'studyFirstSubmitDate': '2011-09-14', 'studyFirstSubmitQcDate': '2011-09-15', 'lastUpdatePostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of Atrial Fibrillation', 'timeFrame': 'four years', 'description': 'Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['paroxysmal atrial fibrillation, hypertension'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS ).\n\nA total of 160 subjects will be included in two study groups. The Group 1 will receive 80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS). Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and 24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg. Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood pressure during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented hypertensive patients with paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.\n* Patients with hypertensive history were at least 5 years. Systolic pressure \\> 140mmHg, \\< 190mmHg, Diastolic pressure \\> 85mmHg. \\< 110mmHg.\n* 40 \\< Age \\< 65 years\n\nExclusion Criteria:\n\n* Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening\n* Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months\n* Direct current (DC) cardioversion within the last 3 months\n* Symptomatic bradycardia\n* Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use\n* Cardiac surgery or cardiac catheter ablation within the last 3 months\n* Typical angina pectoris symptoms at rest or during exercise\n* Known coronary artery disease with indication for intervention\n* Valvular disease \\> II degree\n* Left ventricular ejection fraction \\< 40%\n* Diastolic blood pressure \\> 110mm Hg at rest\n* Symptomatic arterial hypotension\n* Known renal artery stenosis\n* Serum creatinine \\> 1.8 mval/l\n* Relevant hepatic or pulmonary disorders\n* Hyperthyroidism manifested clinically and in laboratory\n* Known drug intolerance for AT II inhibitors\n* Females who are pregnant or breast feeding\n* Females of childbearing potential who are not using a scientifically accepted method of contraception\n* Participation in a clinical trial within the last 30 days\n* Drug addiction or chronic alcohol abuse\n* Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study\n* Evidence of an uncooperative attitude'}, 'identificationModule': {'nctId': 'NCT01435161', 'briefTitle': 'Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure', 'orgStudyIdInfo': {'id': 'NTP-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nifedipine', 'description': 'Patients in arm 1 receive Nifedipine;', 'interventionNames': ['Drug: Nifedipine,']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan', 'description': 'Arm 2 receive telmisartan', 'interventionNames': ['Drug: Telmisartan']}], 'interventions': [{'name': 'Nifedipine,', 'type': 'DRUG', 'otherNames': ['anti-hypertensive drugs, Atrial fibrillation'], 'description': 'Nifedipine 30-60mg/day', 'armGroupLabels': ['Nifedipine']}, {'name': 'Telmisartan', 'type': 'DRUG', 'otherNames': ['anti-hypertensive drugs, atrial fibrillation'], 'description': 'Telmisartan 80-160mg/day', 'armGroupLabels': ['Telmisartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': '2ndChongqingMU', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Yuehui Yin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Dept. of Cardiology, the second affiliated hospital of Chongqing medical university', 'investigatorFullName': 'Yuehui Yin', 'investigatorAffiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}}}}