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

Atrial Fibrillation Clinical Trial

— MRI-AF  

Official title:

Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00951301
• Other study ID #: 07-007749
• Status: Terminated
• Phase: Phase 1
• First received: July 31, 2009
• Last updated: March 14, 2016
• Start date: July 2009
• Est. completion date: June 2013

Study information

• Verified date: March 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs).		6 months	No
Secondary	Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c).		6 months	Yes
Secondary	Quality of life		6 months	No
Secondary	AF recurrence rates between the mangosteen group and the placebo group		6 months	No
Secondary	Associated levels of inflammatory markers with those experiencing recurrent AF		6 months	No