Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00951301

Purpose

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	Intervention	Phase
Atrial Fibrillation	Drug: mangosteen juice Drug: placebo juice	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
AF recurrence rates between the mangosteen group and the placebo group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Associated levels of inflammatory markers with those experiencing recurrent AF [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	July 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951301

Contacts

Contact: Jill M Boyum	507-266-3180	boyum.jill@mayo.edu
Contact: Mary A Phelps, BSN	507-266-4058	phelps.mary@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55902
Principal Investigator: Brent A Bauer, MD
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55902
Contact: Jill M Boyum 507-266-3180 boyum.jill@mayo.edu
Contact: Mary A Phelps, RN 507-266-4058 phelps.mary@mayo.edu
Sub-Investigator: Paul A Friedman, MD
Sub-Investigator: Kristi H Monahan, RN

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Brent A Bauer, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Brent A. Bauer, MD, Mayo Clinic Rochester
ClinicalTrials.gov Identifier:	NCT00951301 History of Changes
Other Study ID Numbers:	07-007749
Study First Received:	July 31, 2009
Last Updated:	January 17, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012