Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

NCT02966899 | Withdrawn

• 1 other identifier: 312231
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary; Hypertension; Steatosis; Right Ventricular Failure

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

Omega-3 fatty acids

EXPERIMENTAL

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.

Dietary Supplement: Omega-3 fatty acids

Interventions

Omega-3 fatty acids DIETARY_SUPPLEMENT

Omega-3 fatty acids

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wen-Chih Wu: lead

Study Sites (1)

Providence VA Medical Center

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Fatty Liver; Heart Failure

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Medical

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

US (1)