Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

Right Ventricular Failure Clinical Trial

Official title:

Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02966899
• Other study ID #: 312231
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2023
• Source: Providence VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hypertension
• Hypertension, Pulmonary
• Pulmonary; Hypertension
• Right Ventricular Failure
• Steatosis

Intervention

Dietary Supplement:
• Omega-3 fatty acids

Locations

Country	Name	City	State
United States	Providence VA Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Wen-Chih Wu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension		6 months
Secondary	Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension		6 months