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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ethan J. Anderson, East Carolina University
ClinicalTrials.gov Identifier:
NCT01046604
First received: January 11, 2010
Last updated: September 6, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Mitral Valve Regurgitation
Left Atrium Dilatation and Hypertrophy
Mitochondrial Dysfunction in the Heart
Cardiomyocyte Apoptosis
Cardiac Inflammation
Drug: Lovaza group
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mitigating Cardiac Inflammation and Oxidative Stress in Atrial Myocardium Via Short-term Lovaza Treatment Prior to Surgery

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Active Comparator: Lovaza treated
This arm will be the group of patients that will be treated with Lovaza prior to undergoing mitral valve repair surgery.
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.
Other Name: omega 3 fatty acid esters

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046604

Locations
United States, North Carolina
Brody School of Medicine
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
GlaxoSmithKline
Investigators
Principal Investigator: Ethan J Anderson, PhD Assistant Professor, Department of Pharmacology and Toxicology, East Carolina University
  More Information

Additional Information:
No publications provided

Responsible Party: Ethan J. Anderson, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01046604     History of Changes
Other Study ID Numbers: ECUomega3-01
Study First Received: January 11, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by East Carolina University:
mitral valve regurgitation
omega 3 fatty acids
fish oil
cardiac
mitochondria
apoptosis
human heart

Additional relevant MeSH terms:
Dilatation, Pathologic
Hypertrophy
Inflammation
Mitral Valve Insufficiency
Pathological Conditions, Anatomical
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014