Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery

Mitral Valve Regurgitation Clinical Trial

Official title:

Mitigating Cardiac Inflammation and Oxidative Stress in Atrial Myocardium Via Short-term Lovaza Treatment Prior to Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01046604
• Other study ID #: ECUomega3-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 11, 2010
• Last updated: September 6, 2013
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In the absence of treatment, severe mitral valve regurgitation (MR) results in left atrium (LA) dilatation and hypertrophy, followed ultimately by left ventricular dysfunction and heart failure. One promising intervention for the prevention of the deleterious effects of pressure overload-induced cardiac hypertrophy and heart failure is dietary supplementation with n-3 polyunsaturated fatty acids (PUFAs). However, the molecular targets and mechanisms by which n-3 PUFAs exert their effects are not completely defined. A possible target of n-3 PUFAs is the mitochondrial membrane which has broad implications given that mitochondrial dysfunction and altered metabolism have been associated with cardiac hypertrophy and heart failure. The investigators have recently identified significant mitochondrial dysfunction in the LA of patients with severe MR, as compared to their non-hypertrophied right atrium (RA). However, the investigators have not addressed the possibility that intervention with purified n-3 PUFAs (Lovaza) could improve mitochondrial function. From a mechanistic perspective, the investigators have observed in vitro that n-3 PUFAs accumulate predominately into the mitochondrial membrane of cardiomyocytes where the investigators believe they exert their effects on the biophysical organization of the membrane. Therefore, the CENTRAL HYPOTHESIS is that administering Lovaza to patients with severe MR will reduce apoptosis and improve mitochondrial function in LA (Aim 1). This change in mitochondrial function will be driven by significant biochemical and biophysical remodeling of the mitochondrial membrane (Aim 2).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients age 18+ undergoing minimally invasive mitral valve repair surgery will be enrolled in this study.

Exclusion Criteria:

• Patients with chronic renal insufficiency

• Chronic obstructive pulmonary disease

• Previous myocardial infarction

• Left ventricular dysfunction (ejection fraction <40%)

• Use of anti-arrhythmic drugs other than beta blockers, and the presence of an implantable defibrillator.

• In addition, patients that have a high dietary intake of fish (= 2 servings/week) or have been taking n-3 PUFA supplements will be excluded.

• Also, patients that are allergic to fish or shellfish, or taking any anticoagulant/antiplatelet medications other than aspirin (e.g. Plavix, Coumadin) will be excluded from this study.

• Patients under the age of 18, and women who are pregnant will be excluded from this study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Inflammation
• Cardiomyocyte Apoptosis
• Hypertrophy
• Inflammation
• Left Atrium Dilatation and Hypertrophy
• Mitochondrial Dysfunction in the Heart
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Drug:
• Lovaza group
Patients who are scheduled for mitral valve repair surgery at least 3 weeks removed from the initial consult will be recruited to take 4 capsules of Lovaza (omega 3 fatty acids) daily, for 3 weeks prior to their surgery.

Locations

Country	Name	City	State
United States	Brody School of Medicine	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium		15 months	No
Secondary	Specific Aim 2: To determine if Lovaza treatment alters the biophysical and biochemical organization of cardiac mitochondrial membranes. The following questions will be addressed using the blood and cardiac tissue samples collected as described above:		15 months	No