Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

Not Applicable

Withdrawn

• Conditions: Pulmonary; Hypertension; Right Ventricular Failure; Steatosis
• Interventions: Dietary Supplement: Omega-3 fatty acids

• Registration Number: NCT02966899
• Lead Sponsor: Wen-Chih Wu

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-17
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acids	Omega-3 fatty acids	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Providence VA Medical Center; 🇺🇸 Providence, Rhode Island, United States