Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial
18 Years
N/A
Both
Atrial Fibrillation
Trial Information
Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
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).
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Brent A Bauer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
07-007749
NCT ID:
NCT00951301
Start Date:
July 2009
Completion Date:
December 2013
Related Keywords:
- Atrial Fibrillation
- Atrial Fibrillation
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
