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

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ClinicalTrials.gov Identifier: NCT01435161
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : November 16, 2012
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University

September 14, 2011
September 16, 2011
November 16, 2012
May 2007
August 2011   (Final data collection date for primary outcome measure)
Recurrence of Atrial Fibrillation [ Time Frame: four years ]
Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)
Same as current
Complete list of historical versions of study NCT01435161 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF
The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: Nifedipine,
    Nifedipine 30-60mg/day
    Other Name: anti-hypertensive drugs, Atrial fibrillation
  • Drug: Telmisartan
    Telmisartan 80-160mg/day
    Other Name: anti-hypertensive drugs, atrial fibrillation
  • Active Comparator: Nifedipine
    Patients in arm 1 receive Nifedipine;
    Intervention: Drug: Nifedipine,
  • Active Comparator: Telmisartan
    Arm 2 receive telmisartan
    Intervention: Drug: Telmisartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Same as current
August 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01435161
NTP-AF
Yes
Not Provided
Not Provided
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
Not Provided
Study Chair: Yuehui Yin, MD The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP