Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF
Information source: The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Nifedipine, (Drug); Telmisartan (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: The Second Affiliated Hospital of Chongqing Medical University Official(s) and/or principal investigator(s): Yuehui Yin, MD, Study Chair, Affiliation: The Second Affiliated Hospital of Chongqing Medical University
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Recurrence of Atrial Fibrillation
Eligibility
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
2ndChongqingMU, Chongqing, Chongqing 400010, China
Additional Information
Starting date: May 2007
Last updated: November 15, 2012
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