Clinical trial NCT02631421: Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH
Official title: Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: PAH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* ≥ 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Peripheral blood oleoylcarnitine in PAH versus control
timeFrame: At time of clinic visit, within 24 hrs prior to right heart catheritization
measure: Percent change across the cardiac circulation of oleate and the glucose/lactate ratio.
timeFrame: At time of right heart catheterization
Secondary outcomes:
measure: 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
timeFrame: At time of clinic visit, within 24hrs prior to right heart catheritization
measure: Correlation of the trans-cardiac gradient of oleate and lactate/glucose with right ventricular ejection fraction on cardiac MRI and six minute walk distance.
timeFrame: At time of right heart catheterization
measure: Measurement of trans-cardiac acylcarnitines
timeFrame: At time of right heart catheterization
measure: Measurement of trans-cardiac and trans-pulmonary glucose metabolites
timeFrame: At time of right heart catheterization
measure: Measurement of trans-cardiac and trans-pulmonary lipid metabolites
timeFrame: At time of right heart catheterization
measure: Measurement of trans-cardiac and trans-pulmonary amino acid metabolites
timeFrame: At time of right heart catheterization
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Univeristy
state: Tennessee
Study officials:
affiliation: Vanderbilt Univerisy
name: Evan Brittain, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: