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

University of North Carolina System

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Lovaza group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01046604

ECUomega3-01

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

No treatment

No Intervention group

Description:

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.

Lovaza treated

Active Comparator group

Description:

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

Treatment:

Drug: Lovaza group