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Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm Clinical research trials and Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm clinical trial. Test subjects typically receive the most effective healthcare possible for their Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm  Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
For Condition: Cerebrovascular Accident,Death, Sudden,Atrial Fibrillation
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.
Details: Primary Hypothesis: The primary objective is to compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm. Secondary Hypotheses: To compare the three therapies in regard to: 1. Frequency of episodes of major and minor strokes. 2. Frequency of episodes of major and minor bleeds. 3. Frequency of sudden death, cardiac mortality, and total mortality. 4. Frequency of life-threatening pro-arrhythmic reactions. 5. Frequency of episodes of congestive heart failure. 6. Frequency of side effects necessitating discontinuation of therapy. 7. Frequency and mean duration of hospitalization directly related to atrial fibrillation or flutter. 8. Mean change in maximal exercise capacity on treadmill during atrial fibrillation or flutter versus sinus rhythm. 9. Time to the development of sinus rhythm from randomization to day 28 of the study. 10. Mean duration of the intervals between occurrences of atrial fibrillation or flutter after day 28. 11. The mean ventricular response documented on electrocardiogram (ECG) recordings during occurrences of atrial fibrillation or flutter after day 28. 12. Changes in health-related quality of life as measured by the SF-36 and an atrial fibrillation quality of life questionnaire. 13. Time to first occurrence of atrial fibrillation or flutter after day 28 or cessation of treatment due to adverse drug reactions after randomization. Intervention: Patients are randomized to amiodarone (400mg bid for 14 days, 400mg qam and d200mg qhs for 14 days, 300mg qd for 48 weeks, then 200mg qd), sotalol 80mg bid for 7 days and 160mg bid thereafter) or placebo. Primary Outcomes: The time from day 28 of randomazation to first occurrence of atrial fibrillation or flutter. Failure time will be set at 0 days for patients who fail to cardiovert at day 28. Study Abstract: Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation. All patients will have atrial fibrillation continuously for greater than 72 hours. Background medications will include warfarin for anticoagulation and digoxin plus diltiazem or verapamil for heart rate control. If warfarin is contraindicated, left atrial thrombus must be excluded by transesophageal echo (TEE) and aspirin 325 mg QD may be used. Patients will be randomly assigned to receive sotalol (80 mg bid for 7 days and 160 mg bid thereafter), amiodarone (400 mg bid for 14 days, 400 mg qam and 200 mg qhs for 14 days, 300 mg qd for 48 weeks, then 200 mg qd) or placebo. Treatment assignment will be stratified by participating hospital, whether the patient has ischemic heart disease and whether the patient is symptomatic. After randomization, patients will stay on drugs for rate control until sinus rhythm is restored and on anticoagulation until two months after sinus rhythm has been restored. After four weeks, patients remaining in atrial fibrillation will undergo DC cardioversion. Those patients not on warfarin must undergo another TEE within 48 hours prior to cardioversion. Patients will have their heart rhythm monitored transtelephonically every week and occurrences of atrial fibrillation or flutter will be documented twice within 24 hours. In the case of documented atrial fibrillation or flutter occurrence, the patient will be re-anticoagulated and at appropriate time subjected to a further DC cardioversion to restore sinus rhythm. Patients in sinus rhythm will be followed until the end of the study. Patients relapsing into AF will be followed a minimum of one year or until relapse, whichever is later. Assuming 35% of patients on placebo, 50% on sotalol, and 60% on amiodarone remain in normal sinus rhythm at the end of one year, a sample size of 706 patients, 279 on amiodarone, 279 on sotalol, and 148 on placebo (85% power and two-sided overall alpha level of 0.05 for the set of three pairwise comparisons) will be needed for these group differences to be statistically significant.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients who have atrial fibrillation continuously for greater than 72 hours.
Total Enrollment: 706
Location and Contact Information:
Vamc - Portland, Or
Portland, Oregon, 97201
United States
Vamc - Nashville, Tn
Nashville, Tennessee, 37232
United States
Vamc - Tucson, Az
Tucson, Arizona, 85723
United States
Vamc - West Los Angeles, Ca
Los Angeles, California, 90073
United States
Vamc - Loma Linda, Ca
Loma Linda, California, 92354
United States
Vamc - Dallas, Tx
Dallas, Texas, 75216
United States
Vamc - Palo Alto, Ca
Palo Alto, California, 94304
United States
Vamc - Sepulveda, Ca
Sepulveda, California, 91343
United States
Vamc - Albuquerque, Nm
Albuquerque, New Mexico, 87108
United States
Vamc - Washington, Dc
Washington D.C., District of Columbia, 20422
United States
Vamc - Richmond, Va
Richmond, Virginia, 23249
United States
Vamc - Memphis, Tn
Memphis, Tennessee, 38104
United States
Vamc - Kansas City, Mo
Kansas City, Missouri, 64128
United States
Vamc - St. Louis, Mo
St. Louis, Missouri, 63106
United States
Vamc - Washington, Dc
Washington D.C., District of Columbia, 20422
United States
Vamc - Pittsburgh, Pa
Pittsburgh, Pennsylvania, 15213-2582
United States
Vamc - Richmond, Va
Richmond, Virginia, 23249
United States
Vamc - Bay Pines, Fl
Bay Pines, Florida, 33504
United States
Vamc - Fresno, Ca
Fresno, California, 93703
United States
Vamc - Pittsburgh, Pa
Pittsburgh, Pennsylvania, 15240
United States
Vamc - Augusta, Ga
Augusta, Georgia, 30904
United States
Vamc - Fargo, Nd
Fargo, North Dakota, 58102
United States
Vamc - Minneapolis, Mn
Minneapolis, Minnesota, 55417
United States
Vamc - Iowa City, Ia
Iowa City, Iowa, 52242
United States
Vamc - West Haven, Ct
West Haven, Connecticut, 06516
United States
Vamc - Providence, Ri
Providence, Rhode Island, 02908-4799
United States
Vamc - West Los Angeles
Los Angeles, California, 90073
United States
Vamc - Hines, Il
Hines, Illinois, 60141-5000
United States
Vamc - Nashville, Tn
Nashville, Tennessee, 37212
United States
Vamc - Brockton (West Roxbury), Ma
West Roxbury, Massachusetts, 02132
United States
Vamc - Little Rock, Ar
Little Rock, Arkansas, 72205
United States
Vamc - Madison, Wi
Madison, Wisconsin, 53705
United States
Vamc - Tampa, Fl
Tampa, Florida, 33612
United States
Additional Information:
Study ID Numbers: 399;
Study Start Date: April 1998
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007605
Other Atrial Fibrillation Studies:
1. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
Related Studies:
Other Atrial Fibrillation Clinical Trials
Other California Clinical Trials
Other Loma Linda Clinical Trials
Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
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