Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631421
• Other study ID #: 140983
• Status: Completed
• Start date: January 2015
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Procedure:
• Blood Sampling

Other:
• Cardiac MRI

Locations

Country	Name	City	State
United States	Vanderbilt Univeristy	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral blood oleoylcarnitine in PAH versus control		At time of clinic visit, within 24 hrs prior to right heart catheritization
Primary	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	At time of right heart catheterization
Secondary	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		At time of clinic visit, within 24hrs prior to right heart catheritization
Secondary	Correlation of the trans-cardiac gradient of oleate and lactate/glucose with right ventricular ejection fraction on cardiac MRI and six minute walk distance.		At time of right heart catheterization
Secondary	Measurement of trans-cardiac acylcarnitines		At time of right heart catheterization
Secondary	Measurement of trans-cardiac and trans-pulmonary glucose metabolites		At time of right heart catheterization
Secondary	Measurement of trans-cardiac and trans-pulmonary lipid metabolites		At time of right heart catheterization
Secondary	Measurement of trans-cardiac and trans-pulmonary amino acid metabolites		At time of right heart catheterization