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

NCT ID: NCT01046604

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-12-31

Brief 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).

Conditions

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

Keywords

mitral valve regurgitation; omega 3 fatty acids; fish oil; cardiac; mitochondria; apoptosis; human heart

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

No treatment

This is the group of patients that will not undergo any treatment with Lovaza prior to mitral valve repair surgery. This is the 'control' group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lovaza treated

This arm will be the group of patients that will be treated with Lovaza prior to undergoing mitral valve repair surgery.

Group Type: ACTIVE_COMPARATOR

Lovaza group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

omega 3 fatty acid esters

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

Ethan J. Anderson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ethan J Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Pharmacology and Toxicology, East Carolina University

Locations

Brody School of Medicine

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

ECUomega3-01

Identifier Type: -

Identifier Source: org_study_id