Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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. The study will also look at the effects the mangosteen juice may have on biomarkers of inflammation and endothelial cell dysfunction (the tissue lining the arteries does not function properly).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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