Atrial Fibrillation
Conditions
Keywords
paroxysmal atrial fibrillation, hypertension
Brief summary
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 ). A 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.
Interventions
DRUGNifedipine,
Nifedipine 30-60mg/day
DRUGTelmisartan
Telmisartan 80-160mg/day
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Patients with hypertensive history were at least 5 years. Systolic pressure \> 140mmHg, \< 190mmHg, Diastolic pressure \> 85mmHg. \< 110mmHg. * 40 \< Age \< 65 years
Exclusion criteria
* Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening * Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months * Direct current (DC) cardioversion within the last 3 months * Symptomatic bradycardia * Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use * Cardiac surgery or cardiac catheter ablation within the last 3 months * Typical angina pectoris symptoms at rest or during exercise * Known coronary artery disease with indication for intervention * Valvular disease \> II degree * Left ventricular ejection fraction \< 40% * Diastolic blood pressure \> 110mm Hg at rest * Symptomatic arterial hypotension * Known renal artery stenosis * Serum creatinine \> 1.8 mval/l * Relevant hepatic or pulmonary disorders * Hyperthyroidism manifested clinically and in laboratory * Known drug intolerance for AT II inhibitors * Females who are pregnant or breast feeding * Females of childbearing potential who are not using a scientifically accepted method of contraception * Participation in a clinical trial within the last 30 days * Drug addiction or chronic alcohol abuse * Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study * Evidence of an uncooperative attitude
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Atrial Fibrillation | four years | Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording) |
Countries
China
Outcome results
None listed