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Clinical Trials/NCT02966899
NCT02966899
Withdrawn
Not Applicable

Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

Wen-Chih Wu1 site in 1 countryNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary; Hypertension
Sponsor
Wen-Chih Wu
Locations
1
Primary Endpoint
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
July 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Wen-Chih Wu
Responsible Party
Sponsor Investigator
Principal Investigator

Wen-Chih Wu

Chief of Medical

Providence VA Medical Center

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

Outcomes

Primary Outcomes

Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension

Time Frame: 6 months

Secondary Outcomes

  • Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension(6 months)

Study Sites (1)

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