Clinical trial NCT02763735: Right Ventricular Metabolism in Pulmonary Arterial Hypertension
Official title: Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Healthy
Keywords: Pulmonary arterial hypertension
Right ventricle
Right ventricular function
Metabolism
Non-invasive imaging
Healthy Subjects
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pulmonary Arterial Hypertension (heritable or idiopathic) Healthy Subjects

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Heritable or idiopathic PAH
* 18 years or older
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Type 1 diabetes mellitus
* Prednisone use
* PAH associated with any condition other than idiopathic or heritable
* Implanted ferromagnetic material incompatible with MRI

Primary outcomes:
measure: Right ventricular oxygen consumption divided by the rate pressure product
timeFrame: At time of C11 acetate PET scan
Secondary outcomes:
measure: Right ventricular oxygen consumption (kmono)
timeFrame: At time of C11 acetate PET scan
measure: Right ventricular glucose uptake (standardized uptake value)
timeFrame: At time of 18-FDG PET scan
measure: Percent myocardial triglyceride content
timeFrame: At time of cardiac magnetic resonance imaging
measure: Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with right ventricular function
timeFrame: Day 1
measure: Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with six minute walk distance
timeFrame: Day 1
measure: Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with plasma metabolic profile
timeFrame: Day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: