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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nifedipine,
Telmisartan
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring paroxysmal atrial fibrillation, hypertension

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 2ndChongqingMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nifedipine

Telmisartan

Arm Description

Patients in arm 1 receive Nifedipine;

Arm 2 receive telmisartan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2011
Last Updated
November 15, 2012
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01435161
Brief Title
Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF
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 Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
paroxysmal atrial fibrillation, hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
Patients in arm 1 receive Nifedipine;
Arm Title
Telmisartan
Arm Type
Active Comparator
Arm Description
Arm 2 receive telmisartan
Intervention Type
Drug
Intervention Name(s)
Nifedipine,
Other Intervention Name(s)
anti-hypertensive drugs, Atrial fibrillation
Intervention Description
Nifedipine 30-60mg/day
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Other Intervention Name(s)
anti-hypertensive drugs, atrial fibrillation
Intervention Description
Telmisartan 80-160mg/day
Primary Outcome Measure Information:
Title
Recurrence of Atrial Fibrillation
Description
Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)
Time Frame
four years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
Organizational Affiliation
The Second Affiliated Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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