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

NCT01435161 | Completed Phase 4 DMC

• 1 other identifier: NTP-AF
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

paroxysmal atrial fibrillation, hypertension

Outcome Measures

Primary Outcomes (1)

• Recurrence of Atrial Fibrillation

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

  four years

Study Arms (2)

Nifedipine

ACTIVE COMPARATOR

Patients in arm 1 receive Nifedipine;

Drug: Nifedipine,

Telmisartan

ACTIVE COMPARATOR

Arm 2 receive telmisartan

Drug: Telmisartan

Interventions

Nifedipine, DRUG

Nifedipine 30-60mg/day

Also known as: anti-hypertensive drugs, Atrial fibrillation

Nifedipine

Telmisartan DRUG

Telmisartan 80-160mg/day

Also known as: anti-hypertensive drugs, atrial fibrillation

Telmisartan

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \< Age \< 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Interventions

Nifedipine; Antihypertensive Agents; Telmisartan

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yuehui Yin, MD

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Dept. of Cardiology, the second affiliated hospital of Chongqing medical university

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 16, 2011
• Study Start: May 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

CN (1)