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

Phase 1

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: mangosteen juice; Drug: placebo juice

• Registration Number: NCT00951301
• Lead Sponsor: Mayo Clinic

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. 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).

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-oxidant properties may effect the measured levels of inflammatory biomarkers. Secondarily, this study will compare the attenuation of markers of endothelial cell dysfunction including endothelial progenitor cells (EPCs), clinical levels of anticoagulation (INR), digoxin, lipids, and glycosylated hemoglobin (Hgb A1c), quality of life measurements, AF recurrences, and associated levels of inflammatory markers with those experiencing recurrent AF between the mangosteen group and the placebo group.

This trial will randomize 250 patients presenting to the Mayo Clinic Cardioversion Unit over one year to two groups including a mangosteen supplemented group versus a control group with placebo juice. Patients will be enrolled who have a history of paroxysmal, persistent, or longstanding persistent atrial fibrillation and excluded if they have a history of recent surgery, myocardial infarction, infection, collagen vascular disease with active inflammation, or thyroid disease. Furthermore, patients already on corticosteroids will be excluded. Patients will be evaluated at enrollment and followed at 3 months and 6 months with repeat ECG, laboratory testing of inflammatory biomarkers and endothelial function, as well as quality of life questions.

The trial will track the effect of natural juices containing anti-inflammatory and anti-oxidant properties on inflammatory markers, endothelial progenitor cells, and quality of life. This trial will attempt to determine if any dietary supplement effects to inflammatory markers correlate with the rate of recurrent AF in each of the two groups.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mangosteen juice	mangosteen juice	subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient
placebo juice	placebo juice	subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient

Primary Outcome Measures

Name	Time	Method
Test the hypothesis that the addition of mangosteen juice as a dietary supplement may reduce the measured levels of inflammatory biomarkers interleukin 1, interleukin 6, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF a) etc).	6 months

Secondary Outcome Measures

Name	Time	Method
attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs).	6 months
Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c).	6 months
Quality of life	6 months
AF recurrence rates between the mangosteen group and the placebo group	6 months
Associated levels of inflammatory markers with those experiencing recurrent AF	6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States