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Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

W

Wen-Chih Wu

Status

Withdrawn

Conditions

Pulmonary; Hypertension
Right Ventricular Failure
Steatosis

Treatments

Dietary Supplement: Omega-3 fatty acids

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Omega-3 fatty acids
Experimental group
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.
Treatment:
Dietary Supplement: Omega-3 fatty acids

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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