Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01046604|
Recruitment Status : Unknown
Verified August 2013 by Ethan J. Anderson, East Carolina University.
Recruitment status was: Active, not recruiting
First Posted : January 12, 2010
Last Update Posted : September 10, 2013
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
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
- Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium [ Time Frame: 15 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046604
|United States, North Carolina|
|Brody School of Medicine|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||Ethan J Anderson, PhD||Assistant Professor, Department of Pharmacology and Toxicology, East Carolina University|