Pulmonary; HypertensionNCT02966899
Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
A study testing Omega-3 fatty acids in people with Pulmonary; Hypertension and Steatosis, run by Wen-Chih Wu at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pulmonary; Hypertension, Steatosis, Right Ventricular Failure
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center
Providence, Rhode Island, 02908
About this study
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.
Read the 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.
- Being tested
- Omega-3 fatty acids
- Medical subject headings
- Hypertension, Pulmonary, Fatty Liver, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
Measured: 6 months
Secondary outcomes (1)
Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: Never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary; HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wen-Chih Wu
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Wen-Chih Wu, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966899
- Sponsor's protocol ID
- 312231
- Status last verified
- Dec 2023
- First submitted
- 11 Nov 2016
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02966899
- Acronym / sponsor ID
- 312231
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wen-Chih WuUS federal agency
- Study start
- Nov 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acids | Experimental | Dietary Supplement: Omega-3 fatty acids30 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acids | Dietary supplement | Omega-3 fatty acids |
Primary outcome
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
Time frame: 6 months
1 secondary outcome
Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids in people with Pulmonary; Hypertension and Steatosis, run by Wen-Chih Wu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.