Pulmonary Arterial HypertensionNCT02763735
Right Ventricular Metabolism in Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension and Healthy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to use non-invasive imaging to determine the metabolic phenotype of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of disease severity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, Healthy
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pulmonary Arterial Hypertension (heritable or idiopathic) Healthy Subjects
Who may be able to join
- Heritable or idiopathic PAH
- 18 years or older
- Able to give informed consent
Who cannot join
- Pregnancy
- Type 1 diabetes mellitus
- Prednisone use
- PAH associated with any condition other than idiopathic or heritable
- Implanted ferromagnetic material incompatible with MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension
The purpose of this study is to use non-invasive imaging to determine the metabolic phenotype of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of disease severity.
Read the detailed description
Current medical therapy for pulmonary arterial hypertension (PAH) is aimed at reducing pulmonary vascular resistance (PVR) but not ameliorating right ventricular (RV) failure, the major cause of death. There are no RV-specific therapies currently available for PAH, in part because the pathophysiology of RV failure is poorly understood.
The investigators hypothesize that the RV in PAH develops a distinct metabolic pattern characterized by increased glycolysis, impaired oxidative metabolism and lipid deposition, which are associated with RV failure.
Specific Aim 1. To test the hypothesis that the RV in human PAH exhibits lipid deposition, increased glycolysis and impaired fatty acid oxidation. The investigators will measure RV oxidative metabolism and glycolysis in PAH patients and controls using positron emission tomography 11C acetate and [18F]fluoro-deoxy-D-glucose imaging and measure myocardial lipid accumulation using magnetic resonance spectroscopy imaging.
Specific Aim 2. To test the hypothesis that an abnormal RV metabolic profile is associated with RV dysfunction and reduced exercise capacity in PAH. PET and MRS findings will be correlated with RV function, patient exercise capacity and a blood metabolic profile.
- Conditions
- Pulmonary Arterial Hypertension, Healthy
- Keywords
- Pulmonary arterial hypertension, Right ventricle, Right ventricular function, Metabolism, Non-invasive imaging, Healthy Subjects
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Arterial Hypertension | Patients diagnosed with idiopathic or heritable pulmonary arterial hypertension according to consensus guidelines. RV oxidative metabolism and glycolysis will be measured using PET 11C acetate and [18F]fluoro-deoxy-Dglucose (FDG) imaging and measure myocardial lipid accumulation using MRS imaging. | |
| Subjects without cardiopulmonary disease | Subjects without known cardiopulmonary disease. RV oxidative metabolism and glycolysis will be measured using PET 11C acetate and [18F]fluoro-deoxy-Dglucose (FDG) imaging and measure myocardial lipid accumulation using MRS imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular oxygen consumption divided by the rate pressure product
kmono divided by the rate pressure product (heart rate X systolic blood pressure)
Measured: At time of C11 acetate PET scan
Secondary outcomes (6)
Right ventricular oxygen consumption (kmono)
Measured: At time of C11 acetate PET scan
Right ventricular glucose uptake (standardized uptake value)
Measured: At time of 18-FDG PET scan
Percent myocardial triglyceride content
Percent of myocardial triglyceride measured in the interventricular septum
Measured: At time of cardiac magnetic resonance imaging
Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with right ventricular function
Measured: Day 1
Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with six minute walk distance
Measured: Day 1
Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with plasma metabolic profile
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2014
- 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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Brittain, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763735
- Sponsor's protocol ID
- 131271
- Status last verified
- May 2020
- First submitted
- 28 Apr 2016
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02763735
- Acronym / sponsor ID
- 131271
- Conditions
- Pulmonary Arterial Hypertension, Healthy
- Keywords
- Pulmonary arterial hypertension, Right ventricle, Right ventricular function, Metabolism, Non-invasive imaging, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 May 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 purpose of this study is to use non-invasive imaging to determine the metabolic phenotype of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of disease severity.
Detailed description
Current medical therapy for pulmonary arterial hypertension (PAH) is aimed at reducing pulmonary vascular resistance (PVR) but not ameliorating right ventricular (RV) failure, the major cause of death. There are no RV-specific therapies currently available for PAH, in part because the pathophysiology of RV failure is poorly understood.
The investigators hypothesize that the RV in PAH develops a distinct metabolic pattern characterized by increased glycolysis, impaired oxidative metabolism and lipid deposition, which are associated with RV failure.
Specific Aim 1. To test the hypothesis that the RV in human PAH exhibits lipid deposition, increased glycolysis and impaired fatty acid oxidation. The investigators will measure RV oxidative metabolism and glycolysis in PAH patients and controls using positron emission tomography 11C acetate and [18F]fluoro-deoxy-D-glucose imaging and measure myocardial lipid accumulation using magnetic resonance spectroscopy imaging.
Specific Aim 2. To test the hypothesis that an abnormal RV metabolic profile is associated with RV dysfunction and reduced exercise capacity in PAH. PET and MRS findings will be correlated with RV function, patient exercise capacity and a blood metabolic profile.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Arterial Hypertension | – | –Patients diagnosed with idiopathic or heritable pulmonary arterial hypertension according to consensus guidelines. RV oxidative metabolism and glycolysis will be measured using PET 11C acetate and [18F]fluoro-deoxy-Dglucose (FDG) imaging and measure myocardial lipid accumulation using MRS imaging. |
| Subjects without cardiopulmonary disease | – | –Subjects without known cardiopulmonary disease. RV oxidative metabolism and glycolysis will be measured using PET 11C acetate and [18F]fluoro-deoxy-Dglucose (FDG) imaging and measure myocardial lipid accumulation using MRS imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Arterial Hypertension (heritable or idiopathic) Healthy Subjects
Key inclusion criteria (3 listed)
- Heritable or idiopathic PAH
- 18 years or older
- Able to give informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Type 1 diabetes mellitus
- Prednisone use
- PAH associated with any condition other than idiopathic or heritable
- Implanted ferromagnetic material incompatible with MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Right ventricular oxygen consumption divided by the rate pressure product
Time frame: At time of C11 acetate PET scan
kmono divided by the rate pressure product (heart rate X systolic blood pressure)
6 secondary outcomes
Right ventricular oxygen consumption (kmono)
Time frame: At time of C11 acetate PET scan
Right ventricular glucose uptake (standardized uptake value)
Time frame: At time of 18-FDG PET scan
Percent myocardial triglyceride content
Time frame: At time of cardiac magnetic resonance imaging
Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with right ventricular function
Time frame: Day 1
Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with six minute walk distance
Time frame: Day 1
Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with plasma metabolic profile
Time frame: Day 1
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 20 May 2020.
- Individual participant dataSharing planned: No
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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?
An observational study of Pulmonary Arterial Hypertension and Healthy, run by Vanderbilt University Medical Center 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 20 May 2020. 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?
Right ventricular oxygen consumption divided by the rate pressure product (time frame: At time of C11 acetate PET scan). 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 20 May 2020.