Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Nifedipine,
* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nifedipine<br>Patients in arm 1 receive Nifedipine; | Drug: Nifedipine,<br>* Nifedipine 30-60mg/day<br>* Other names: anti-hypertensive drugs, Atrial fibrillation;|
| Active Comparator: Telmisartan<br>Arm 2 receive telmisartan | Drug: Telmisartan<br>* Telmisartan 80-160mg/day<br>* Other names: anti-hypertensive drugs, atrial fibrillation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Atrial Fibrillation | Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording) | four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paroxysmal atrial fibrillation, hypertension