Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

December 6, 2023 updated by: Wen-Chih Wu
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / 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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Omega-3 fatty acids

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wen-Chih Wu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Estimated)

July 1, 2017

Study Completion (Estimated)

July 1, 2017

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimated)

November 17, 2016

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 312231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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