Mitral Valve RegurgitationPhase 4NCT01046604
Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery
A Phase 4 study testing Lovaza group in people with Mitral Valve Regurgitation and Left Atrium Dilatation and Hypertrophy, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mitral Valve Regurgitation, Left Atrium Dilatation and Hypertrophy, Mitochondrial Dysfunction in the Heart
- What is being tested?
- Lovaza group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18+ undergoing minimally invasive mitral valve repair surgery will be enrolled in this study.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Brody School of Medicine
Greenville, North Carolina, 27834
About this study
Official title: Mitigating Cardiac Inflammation and Oxidative Stress in Atrial Myocardium Via Short-term Lovaza Treatment Prior to Surgery
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
- Being tested
- Lovaza group
- Keywords
- mitral valve regurgitation, omega 3 fatty acids, fish oil, cardiac, mitochondria, apoptosis, human heart
- Medical subject headings
- Mitral Valve Insufficiency, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza groupDrug
Also called omega 3 fatty acid esters
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.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | 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 | This arm will be the group of patients that will be treated with Lovaza prior to undergoing mitral valve repair surgery. Receives: Drug: Lovaza group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium
Measured: 15 months
Secondary outcomes (1)
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:
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Ethan J. Anderson, East Carolina University
- Investigators
- Ethan J Anderson, PhD, Principal investigator, Assistant Professor, Department of Pharmacology and Toxicology, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046604
- Sponsor's protocol ID
- ECUomega3-01
- Status last verified
- Aug 2013
- First submitted
- 11 Jan 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Cardiac Inflammation and Oxidative Stress in Atrial Myocardium Via Short-term Lovaza Treatment Prior to Surgery
- ClinicalTrials.gov ID
- NCT01046604
- Acronym / sponsor ID
- ECUomega3-01
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –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 | Drug: Lovaza groupThis arm will be the group of patients that will be treated with Lovaza prior to undergoing mitral valve repair surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients age 18+ undergoing minimally invasive mitral valve repair surgery will be enrolled in this study.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovaza groupAlso: omega 3 fatty acid estersPatients 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. | Drug | Lovaza treated |
Primary outcome
Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium
Time frame: 15 months
1 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:
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan J Anderson, PhD principal investigator
Assistant Professor, Department of Pharmacology and Toxicology, East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lovaza group in people with Mitral Valve Regurgitation and Left Atrium Dilatation and Hypertrophy, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Aim 1: To determine if Lovaza treatment reduces markers of inflammation and improves mitochondrial function in atrial myocardium (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.