Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02966899

Enrollment

Registered

2016-11-17

Start date

2016-11-30

Completion date

2017-07-31

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary; Hypertension, Right Ventricular Failure, Steatosis

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 fatty acids

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension	6 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026