Back to resultsReversal of Right Ventricular Steatosis in Pulmonary Hypertension
Primary Purpose
Pulmonary; Hypertension, Steatosis, Right Ventricular Failure
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary; Hypertension
Eligibility Criteria
Inclusion Criteria:
- Adult men and women > 30 years of age with a diagnosis of pulmonary hypertension (defined as mean pulmonary arterial pressure ≥25 mmHg at rest on right heart catheterization)
Exclusion Criteria:
- Contraindication to MRI (e.g., metallic hazards or allergy to gadolinium)
- Renal dysfunction (eGFR < 60 ml/min/1.73m2 as estimated by the Modified Diet in Renal Disease formula)
- High risk features for nephrogenic systemic fibrosis (solitary kidney or prior renal transplant)
- Active pregnancy or breastfeeding (determined by urinary pregnancy test before CMR)
- Weight > 550 lb or waist diameter > 70 cm (limits for our Siemens Verio CMR system)
- Fish Allergy
Sites / Locations
- Providence VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omega-3 fatty acids
Arm Description
30 patients with pulmonary hypertension who are identified as having elevated myocardial triglyceride content by cardiac MRI will receive 4 grams/day of omega-3 fatty acids for six months.
Outcomes
Primary Outcome Measures
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
Secondary Outcome Measures
Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension
Full Information
NCT ID
NCT02966899
First Posted
November 11, 2016
Last Updated
November 16, 2016
Sponsor
Providence VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02966899
Brief Title
Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
Official Title
Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Providence VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to elucidate the relationship between myocardial right ventricular triglyceride content (steatosis) and right ventricular dysfunction in participants with pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty acid treatment.
Detailed Description
The investigators propose to treat 30 participants that are identified as having elevated myocardial triglyceride content (defined as greater than 0.50%) on cardiac MRI with 4 grams of omega-3 fatty acids daily for six months with a primary end point of reducing right ventricular steatosis and a secondary endpoint of improving RV systolic function. The investigators hypothesize that right ventricular steatosis by cardiac MRI will be associated with the degree of right ventricular systolic function by cardiac MRI. In the subset of participants with elevated baseline steatosis who are treated with a lipoprotective strategy, the investigators hypothesize that six months of therapy with omega-3 fatty acids will reduce myocardial steatosis and improve right ventricular systolic function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary; Hypertension, Steatosis, Right Ventricular Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 fatty acids
Arm Type
Experimental
Arm Description
30 patients with pulmonary hypertension who are identified as having elevated myocardial triglyceride content by cardiac MRI will receive 4 grams/day of omega-3 fatty acids for six months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Primary Outcome Measure Information:
Title
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men and women > 30 years of age with a diagnosis of pulmonary hypertension (defined as mean pulmonary arterial pressure ≥25 mmHg at rest on right heart catheterization)
Exclusion Criteria:
Contraindication to MRI (e.g., metallic hazards or allergy to gadolinium)
Renal dysfunction (eGFR < 60 ml/min/1.73m2 as estimated by the Modified Diet in Renal Disease formula)
High risk features for nephrogenic systemic fibrosis (solitary kidney or prior renal transplant)
Active pregnancy or breastfeeding (determined by urinary pregnancy test before CMR)
Weight > 550 lb or waist diameter > 70 cm (limits for our Siemens Verio CMR system)
Fish Allergy
Facility Information:
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddique A Abbasi, MD
Phone
401-273-7100
Ext
2265
Email
siddique_abbasi@brown.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
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