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Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

NCT ID: NCT02966899

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Pulmonary; Hypertension Steatosis Right Ventricular Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wen-Chih Wu

FED

Sponsor Role lead

Responsible Party

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Wen-Chih Wu

Chief of Medical

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Providence VA Medical Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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312231

Identifier Type: -

Identifier Source: org_study_id