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

Sponsor:	Chung Shan Medical University
Information provided by:	Chung Shan Medical University
ClinicalTrials.gov Identifier:	NCT00647257

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Losartan Losartan potassium

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 February 09, 2012