The Effect of Losartan on Atrial Fibrillation (AF) Burden and Pacemaker Dependence in Patients With Sick Sinus Syndrome

NCT00647257 | Unknown DMC

• 1 other identifier: COZ-002-00-28SEP2007
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This is a an investigator-initial, multicenter, open-label, randomized, parallel-group comparative study to evaluate the effect on the incidence of AF and pacemaker dependence in SSS patients receiving physiological atrial-based pacing alone or adding losartan 100mg to physiological atrial-based pacing treatment. The duration of the study will be approximately 13 months, comprising 4-week pre-study period, and 12-month treatment period.

Conditions

Atrial Fibrillation

Keywords

Sick Sinus Syndrome; Atrial Fibrillation; Pacemaker

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who developed AF burden by pacemaker telemetry and developed permanent AF

  12-month study period(2-week + 2-week + 4-week + 4-week + 3-month + 3-month + 3-month)

Secondary Outcomes (1)

• The time to first occurrence of AF lasting for at least 1 minute after pacemaker insertion, and the AF burden over time measured as the portion of AF per day (in hours/day)

  12-month study period(2-week + 2-week + 4-week + 4-week + 3-month + 3-month + 3-month)

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Losartan

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Losartan DRUG

Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Losartan 100mg add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.

A

Placebo DRUG

Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Placebo add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.

B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is willing to sign informed consent form.
• Men or women ≧ 20 and ≦ 80 years of age.
• Symptomatic bradycardia \< 40 beats/min or symptomatic QRS pauses of more than two seconds.
• Normal AV conduction (PQ interval ≦ 220 ms for patients≦ 70 years and a PQ interval ≦ 260 ms for patients \>70 years), and no bundle branch block (QRS width \< 120 ms)

You may not qualify if:

• Patient has history of known intolerance, contraindication or hypersensitivity to losartan.
• st, 2nd or 3rd AV block
• Permanent or therapy refractory AF
• Blood pressure \> 250/120 mmHg at visit 1.
• Heart Failure acc. NYHA III or IV
• Myocardial infarction less than 6 months before pacemaker implant (visit 1)
• Cerebral disease or stroke less than 6 months before pacemaker implant (visit 1)
• Hypertrophic obstructive cardiomyopathy
• Symptomatic hypo- or hyperthyroidism
• Cardiogenic shock
• Women who are pregnant or lactating.
• Unstable angina pectoris
• Patients under 20 years of age
• Patients involved in other studies
• Systolic pressure \< 100 mmHg at the visit 1

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Sick Sinus Syndrome

Interventions

Losartan

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Kwo-Chang Ueng, MD; PhD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwo-Chang Ueng, MD; PhD

CONTACT

886-912385087; ueng.kc@msa.hinet.net; nstudy.lee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: April 1, 2010

Record last verified: 2010-03

Locations

TW (1)