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

NCT00951301 | Terminated Phase 1 DMC

• 1 other identifier: 07-007749
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (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).

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

mangosteen juice

ACTIVE COMPARATOR

subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient

Drug: mangosteen juice

placebo juice

PLACEBO COMPARATOR

subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient

Drug: placebo juice

Interventions

mangosteen juice DRUG

6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation.

Also known as: Xango juice

mangosteen juice

placebo juice DRUG

6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation.

placebo juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent A Bauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 16, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)