Status:
TERMINATED
Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation
Lead Sponsor:
Mayo Clinic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being done to see if the addition of mangosteen juice to standard medical care will reduce the risk of atrial fibrillation (AF) recurrence following direct current (DC) cardioversion. Th...
Detailed Description
Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial is a study designed to test the primary hypothesis that a dietary supplement (Mangosteen) containing anti-inflammatory and anti-...
Eligibility Criteria
Inclusion
- Candidates for this study must meet all of the following criteria:
- Age \>18 years
- Documented atrial fibrillation with a clinically indicated cardioversion.
- Anticoagulation with therapeutic INR or PTT as per Mayo Clinic cardioversion guidelines.
- Provision of written informed consent.
Exclusion
- Subjects will be excluded if any of the following conditions apply:
- Presence of atrial fibrillation secondary to a reversible cause such as thyrotoxicosis or alcohol use
- Myocardial infarction within 1 month, CABG or cardiac surgery including surgical maze or AF radiofrequency ablation within the past 3 months
- Presence of an implanted pacemaker, atrial defibrillator, or ventricular defibrillator
- History of bleeding diathesis or coagulopathy
- Known atrial thrombus or contra-indication to cardioversion
- Active infection or collagen vascular disease with active inflammation
- Current use of corticosteroids
- Gastrointestinal (GI) or genitourinary bleed within the past six months requiring transfusion
- Concomitant medical illness (i.e., cancer, congestive heart failure) that may preclude protocol compliance, confound data interpretation or limit life-expectancy to less than one year
- Known allergy to juice components
- Inability or refusal to cooperate with study procedures
- Unsuccessful cardioversion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00951301
Start Date
July 1 2009
End Date
June 1 2013
Last Update
March 16 2016
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55902