Pulmonary Arterial HypertensionNCT02631421
Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH
An observational study of Pulmonary Arterial Hypertension, run by Vanderbilt University at 1 site in United States.
Trial summary
Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial hypertension (PAH). No RV-specific therapies are available, in part because the underlying mechanisms of RV dysfunction are poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Blood Sampling and Cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PAH
Who may be able to join
- ≥ 18 years old
- Scheduled to undergo cardiac catheterization (right ± left heart catheterization) and/or electrophysiology study in the VHVI cardiac catheterization laboratory (CCL)/electrophysiology laboratory (EP lab)
- Hemoglobin value ≥ 10 g/dL or hematocrit of ≥ 30% (measured on clinically-indicated blood draw within 30 days or a point-of-care measurement in CCL/EP Laboratory if clinically-indicated value is not available)
Who cannot join
- Any individual that is anemic and has a hemoglobin value < 10 g/dL and hematocrit of < 30% will be excluded from the study.
- If a physician performing the procedure believes that performing the extra steps and /or acquiring the additional blood samples will delay or otherwise compromise participants' care, he/she can abandon acquisition of those data at his/her discretion.
- Contraindication to cardiac MRI (applies only to patients undergoing CMR as part of this protocol).
- Implanted ferromagnetic material
- Glomerular filtration rate < 60mL/min (measured on clinically-indicated blood draw within 30 days of CMR or a point-of-care measurement in the CMR Laboratory if clinically-indicated GFR is not available)
Trial locations and contacts
1 site in 1 country.
About this study
Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial hypertension (PAH). No RV-specific therapies are available, in part because the underlying mechanisms of RV dysfunction are poorly understood. Given the heart's preference for fatty acids (FA) as an energy source, a deeper understanding of FA metabolism may shed light on RV adaptation to elevated afterload in PAH. The purpose of this study is to test the hypothesis that defects in fatty acid metabolism are common in PAH and contribute to RV failure. The investigators will measure peripheral and transcardiac lipid and glucose metabolites in PAH patients in comparison with patients with pulmonary venous hypertension and no evidence of pulmonary hypertension. The investigators will also correlate metabolites with concurrent measurement of right ventricular function.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Blood Sampling, Cardiac MRI
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingProcedure or surgery
Cardiac MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Arterial Hypertension | Clinical diagnosis of pulmonary arterial hypertension Receives: Procedure: Blood Sampling; Other: Cardiac MRI | |
| Healthy subjects and patients with other causes of PH | Patients referred for right heart catheterization who do not have PAH Receives: Procedure: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood oleoylcarnitine in PAH versus control
Measured: At time of clinic visit, within 24 hrs prior to right heart catheritization
Percent change across the cardiac circulation of oleate and the glucose/lactate ratio.
The combination of these findings will indicate if there is a decreased reliance on FAO and and increased glycolysis
Measured: At time of right heart catheterization
Secondary outcomes (6)
Correlation of oleoylcarnitine, other acylcarnitines and free fatty acids with the homeostatic index of insulin resistance, tricuspid annular plane systolic excursion, and six minute walk distance
Measured: At time of clinic visit, within 24hrs prior to right heart catheritization
Correlation of the trans-cardiac gradient of oleate and lactate/glucose with right ventricular ejection fraction on cardiac MRI and six minute walk distance.
Measured: At time of right heart catheterization
Measurement of trans-cardiac acylcarnitines
Measured: At time of right heart catheterization
Measurement of trans-cardiac and trans-pulmonary glucose metabolites
Measured: At time of right heart catheterization
Measurement of trans-cardiac and trans-pulmonary lipid metabolites
Measured: At time of right heart catheterization
Measurement of trans-cardiac and trans-pulmonary amino acid metabolites
Measured: At time of right heart catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Brittain, Vanderbilt University
- Investigators
- Evan Brittain, MD, MSCI, Principal investigator, Vanderbilt Univerisy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631421
- Sponsor's protocol ID
- 140983
- Status last verified
- Jul 2019
- First submitted
- 12 Dec 2014
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH
- ClinicalTrials.gov ID
- NCT02631421
- Acronym / sponsor ID
- 140983
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 16 Dec 2015 (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.
Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial hypertension (PAH). No RV-specific therapies are available, in part because the underlying mechanisms of RV dysfunction are poorly understood. Given the heart's preference for fatty acids (FA) as an energy source, a deeper understanding of FA metabolism may shed light on RV adaptation to elevated afterload in PAH. The purpose of this study is to test the hypothesis that defects in fatty acid metabolism are common in PAH and contribute to RV failure. The investigators will measure peripheral and transcardiac lipid and glucose metabolites in PAH patients in comparison with patients with pulmonary venous hypertension and no evidence of pulmonary hypertension. The investigators will also correlate metabolites with concurrent measurement of right ventricular function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Arterial Hypertension | – | Procedure: Blood Sampling, Other: Cardiac MRIClinical diagnosis of pulmonary arterial hypertension |
| Healthy subjects and patients with other causes of PH | – | Procedure: Blood SamplingPatients referred for right heart catheterization who do not have PAH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAH
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Scheduled to undergo cardiac catheterization (right ± left heart catheterization) and/or electrophysiology study in the VHVI cardiac catheterization laboratory (CCL)/electrophysiology laboratory (EP lab)
- Hemoglobin value ≥ 10 g/dL or hematocrit of ≥ 30% (measured on clinically-indicated blood draw within 30 days or a point-of-care measurement in CCL/EP Laboratory if clinically-indicated value is not available)
Key exclusion criteria (5 listed)
- Any individual that is anemic and has a hemoglobin value < 10 g/dL and hematocrit of < 30% will be excluded from the study.
- If a physician performing the procedure believes that performing the extra steps and /or acquiring the additional blood samples will delay or otherwise compromise participants' care, he/she can abandon acquisition of those data at his/her discretion.
- Contraindication to cardiac MRI (applies only to patients undergoing CMR as part of this protocol).
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 |
|---|---|---|
| Blood Sampling | Procedure or surgery | Healthy subjects and patients with other causes of PH, Pulmonary Arterial Hypertension |
| Cardiac MRI | Other | Pulmonary Arterial Hypertension |
Primary outcome
Peripheral blood oleoylcarnitine in PAH versus control
Time frame: At time of clinic visit, within 24 hrs prior to right heart catheritization
Percent change across the cardiac circulation of oleate and the glucose/lactate ratio.
Time frame: At time of right heart catheterization
The combination of these findings will indicate if there is a decreased reliance on FAO and and increased glycolysis
6 secondary outcomes
Correlation of oleoylcarnitine, other acylcarnitines and free fatty acids with the homeostatic index of insulin resistance, tricuspid annular plane systolic excursion, and six minute walk distance
Time frame: At time of clinic visit, within 24hrs prior to right heart catheritization
Correlation of the trans-cardiac gradient of oleate and lactate/glucose with right ventricular ejection fraction on cardiac MRI and six minute walk distance.
Time frame: At time of right heart catheterization
Measurement of trans-cardiac acylcarnitines
Time frame: At time of right heart catheterization
Measurement of trans-cardiac and trans-pulmonary glucose metabolites
Time frame: At time of right heart catheterization
Measurement of trans-cardiac and trans-pulmonary lipid metabolites
Time frame: At time of right heart catheterization
Measurement of trans-cardiac and trans-pulmonary amino acid metabolites
Time frame: At time of right heart catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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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.
Evan Brittain, MD, MSCI principal investigator
Vanderbilt Univerisy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Vanderbilt University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peripheral blood oleoylcarnitine in PAH versus control (time frame: At time of clinic visit, within 24 hrs prior to right heart catheritization). The study lists 2 primary outcomes in all. 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 16 Jul 2019.