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

Overview

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.

Full Title of Study: “The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2011

Interventions

  • Drug: Nifedipine,
    • Nifedipine 30-60mg/day
  • Drug: Telmisartan
    • Telmisartan 80-160mg/day

Arms, Groups and Cohorts

  • Active Comparator: Nifedipine
    • Patients in arm 1 receive Nifedipine;
  • Active Comparator: Telmisartan
    • Arm 2 receive telmisartan

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence of Atrial Fibrillation
    • Time Frame: four years
    • Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Second Affiliated Hospital of Chongqing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuehui Yin, Chief, Dept. of Cardiology, the second affiliated hospital of Chongqing medical university – The Second Affiliated Hospital of Chongqing Medical University
  • Overall Official(s)
    • Yuehui Yin, MD, Study Chair, The Second Affiliated Hospital of Chongqing Medical University

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