Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery
Information source: East Carolina University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mitral Valve Regurgitation; Left Atrium Dilatation and Hypertrophy; Mitochondrial Dysfunction in the Heart; Cardiomyocyte Apoptosis; Cardiac Inflammation
Intervention: Lovaza group (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: East Carolina University Official(s) and/or principal investigator(s): Ethan J Anderson, PhD, Principal Investigator, Affiliation: Assistant Professor, Department of Pharmacology and Toxicology, East Carolina University
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).
Clinical Details
Official title: Mitigating Cardiac Inflammation and Oxidative Stress in Atrial Myocardium Via Short-term Lovaza Treatment Prior to Surgery
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium
Secondary outcome: 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:
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Brody School of Medicine, Greenville, North Carolina 27834, United States
Additional Information
Brief overview of project and investigator background
Starting date: January 2010
Last updated: September 6, 2013
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