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Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation (MRI-AF)

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ClinicalTrials.gov Identifier: NCT00951301
Recruitment Status : Terminated (Significantly lower accrual rate than anticipated, time constraints.)
First Posted : August 4, 2009
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Brent A. Bauer, 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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: mangosteen juice Drug: placebo juice Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial
Study Start Date : July 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: mangosteen juice
subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient
Drug: mangosteen juice
6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation.
Other Name: Xango juice
Placebo Comparator: placebo juice
subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient
Drug: placebo juice
6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation.



Primary Outcome Measures :
  1. 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). [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs). [ Time Frame: 6 months ]
  2. Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c). [ Time Frame: 6 months ]
  3. Quality of life [ Time Frame: 6 months ]
  4. AF recurrence rates between the mangosteen group and the placebo group [ Time Frame: 6 months ]
  5. Associated levels of inflammatory markers with those experiencing recurrent AF [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951301


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Brent A Bauer, MD Mayo Clinic

Responsible Party: Brent A. Bauer, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00951301     History of Changes
Other Study ID Numbers: 07-007749
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes