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

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Telmisartan; Drug: Nifedipine,

• Registration Number: NCT01435161
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan	Telmisartan	Arm 2 receive telmisartan
Nifedipine	Nifedipine,	Patients in arm 1 receive Nifedipine;

Primary Outcome Measures

Name	Time	Method
Recurrence of Atrial Fibrillation	four years	Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)

Trial Locations

Locations (1)

2ndChongqingMU; 🇨🇳 Chongqing, Chongqing, China