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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435161
• Other study ID #: NTP-AF
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2011
• Last updated: November 15, 2012
• Start date: May 2007
• Est. completion date: August 2011

Study information

• Verified date: November 2012
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Clinical Pharmacological Base of 2ndChongqingMU
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Nifedipine,
Nifedipine 30-60mg/day
• Telmisartan
Telmisartan 80-160mg/day

Locations

Country	Name	City	State
China	2ndChongqingMU	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Atrial Fibrillation	Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)	four years	Yes