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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nifedipine,

Drug

Nifedipine 30-60mg/day

Other names: anti-hypertensive drugs, Atrial fibrillation

Telmisartan

Drug

Telmisartan 80-160mg/day

Other names: anti-hypertensive drugs, atrial fibrillation

Primary outcomes

Recurrence of Atrial Fibrillation

Time frame: four years

Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Sep 16, 2011
Registry last updated: Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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