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Completed

NCT Number: NCT02631421

Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt Univeristy

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sampling

Procedure

Cardiac MRI

Other

Primary outcomes

  1. Peripheral blood oleoylcarnitine in PAH versus control

    Time frame: At time of clinic visit, within 24 hrs prior to right heart catheritization

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Measurement of trans-cardiac acylcarnitines

    Time frame: At time of right heart catheterization

  4. Measurement of trans-cardiac and trans-pulmonary glucose metabolites

    Time frame: At time of right heart catheterization

  5. Measurement of trans-cardiac and trans-pulmonary lipid metabolites

    Time frame: At time of right heart catheterization

  6. Measurement of trans-cardiac and trans-pulmonary amino acid metabolites

    Time frame: At time of right heart catheterization

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2015
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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