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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Treatments: Antihypertensive Agents; Nifedipine; Telmisartan

Criteria

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