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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Chung Shan Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT00647257
First received: March 26, 2008
Last updated: March 31, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Drug: Losartan
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Losartan on Atrial Fibrillation and Pacemaker Dependence in Sick Sinus Syndrome (SSS) Patients Receiving Physiological Pacemaker - A Prospective, Randomized, Multicenter Study in Taiwan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chung Shan Medical University:

Primary Outcome Measures:
  • The proportion of patients who developed AF burden by pacemaker telemetry and developed permanent AF [ Time Frame: 12-month study period(2-week + 2-week + 4-week + 4-week + 3-month + 3-month + 3-month) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 12-month study period(2-week + 2-week + 4-week + 4-week + 3-month + 3-month + 3-month) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Losartan
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.
Placebo Comparator: B Drug: Placebo
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.

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  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patient has history of known intolerance, contraindication or hypersensitivity to losartan.
  • 1st, 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
  • Reduced expectancy of life due to other diseases
  • Patients who cannot attend follow-up visits regularly
  • Patient has clinically important abnormal laboratory findings at the visit 1 local laboratory screen including: Serum creatinine > 2.5 mg/dL; Serum potassium < 3.5 or > 5.7 eEq/L; SGOT/SGPT (ALT/AST) > 3 times of the upper normal limits; Blood hemoglobin (males & females < 10 g/dL)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647257

Contacts
Contact: Kwo-Chang Ueng, MD; PhD 886-912385087 ueng.kc@msa.hinet.net; nstudy.lee@gmail.com

Locations
Taiwan
Chung Shan Medical University Hospital Recruiting
Taichung, Taiwan, 402
Contact: Kwo-Chang Ueng, MD; PhD     886-4-24739595 ext 38231     ueng.kc@msa.hinet.net; nstudy.lee@gmail.com    
Principal Investigator: Kwo-Chang Ueng, MD; PhD            
Sponsors and Collaborators
Chung Shan Medical University
Investigators
Principal Investigator: Kwo-Chang Ueng, MD; PhD Chung Shan Medical University Hospital
  More Information

No publications provided

Responsible Party: Kwo-Chang Ueng, Chung Shan Medical University Hospital
ClinicalTrials.gov Identifier: NCT00647257     History of Changes
Other Study ID Numbers: COZ-002-00-28SEP2007
Study First Received: March 26, 2008
Last Updated: March 31, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chung Shan Medical University:
Sick Sinus Syndrome; Atrial Fibrillation; Pacemaker

Additional relevant MeSH terms:
Atrial Fibrillation
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block
Losartan
 Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013