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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01435161
First received: September 14, 2011
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Nifedipine,
Drug: Telmisartan
Phase 4

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

Resource links provided by NLM:


Further study details as provided by The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • Recurrence of Atrial Fibrillation [ Time Frame: four years ] [ Designated as safety issue: Yes ]
    Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)


Enrollment: 160
Study Start Date: May 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nifedipine
Patients in arm 1 receive Nifedipine;
Drug: Nifedipine,
Nifedipine 30-60mg/day
Other Name: anti-hypertensive drugs, Atrial fibrillation
Active Comparator: Telmisartan
Arm 2 receive telmisartan
Drug: Telmisartan
Telmisartan 80-160mg/day
Other Name: anti-hypertensive drugs, atrial fibrillation

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435161

Locations
China, Chongqing
2ndChongqingMU
Chongqing, Chongqing, China, 400010
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Investigators
Study Chair: Yuehui Yin, MD The Second Affiliated Hospital of Chongqing Medical University
  More Information

No publications provided

Responsible Party: Yuehui Yin, Chief, Dept. of Cardiology, the second affiliated hospital of Chongqing medical university, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01435161     History of Changes
Other Study ID Numbers: NTP-AF
Study First Received: September 14, 2011
Last Updated: November 15, 2012
Health Authority: China: Clinical Pharmacological Base of 2ndChongqingMU

Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
paroxysmal atrial fibrillation, hypertension

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Antihypertensive Agents
Nifedipine
Telmisartan
Benzoates
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 22, 2014