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

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Telmisartan; Drug: Nifedipine,

Study type: Interventional

Funder types: Other

Identifiers

NCT01435161

NTP-AF

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Nifedipine

Active Comparator group

Description:

Patients in arm 1 receive Nifedipine;

Treatment:

Drug: Nifedipine,

Telmisartan

Active Comparator group

Description:

Arm 2 receive telmisartan

Treatment:

Drug: Telmisartan