DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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


Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017