Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01520493
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2012-01-25
Brief Title:
Peripheral Muscle Microcirculation and Exercise-induced Blood Flow Distribution in Pulmonary Arterial Hypertension
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Peripheral Muscle Microcirculation and Exercise-induced Blood Flow Distribution in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary artery hypertension PAH is a rare severe disease characterized by a progressive increase in pulmonary vascular resistance ultimately leading to right ventricular RV failure and premature death PAH may be idiopathic IPAH or may be also related to various conditions like portal hypertension HIV infection left to right shunt connective tissue diseases such as scleroderma PAHSSc Symptoms include dyspnea and fatigue resulting in restricted exercise capacity and poor quality of life The therapies currently approved have been shown to improve survival Indeed recent studies described a three year survival higher than 80 This improved survival is associated with major challenges for clinicians as most patients remain with limited exercise capacity and poor quality of life A clear understanding of exercise physiopathology is thus mandatory to specifically address mechanisms responsible for this exercise limitation and eventually improve patients management In order to better characterize the exercise physiopathology in PAH the general objective of this research is to systematically examine blood flow distribution and limb muscles microcirculation at rest and during submaximal exercise in PAH
Detailed Description:
Pulmonary artery hypertension PAH is a rare severe disease characterized by a progressive increase in pulmonary vascular resistance ultimately leading to right ventricular RV failure and premature death PAH may be idiopathic IPAH or may be also related to various conditions like portal hypertension HIV infection left to right shunt connective tissue diseases such as scleroderma PAHSSc PAH is defined as a mean pulmonary artery pressure mPAP of 25 mmHg at rest Symptoms include dyspnea and fatigue resulting in restricted exercise capacity and poor quality of life The agents currently approved for treatment of PAH are prostanoids iv epoprostenol or sciv treprostinil endothelin-receptor antagonists ambrisentan bosentan and sitaxsentan and phosphodiesterase type 5-inhibitors sildenafil and tadalafil These therapies have been shown to improve pulmonary hemodynamics exercise capacity quality of life and survival Indeed recent studies described a three year survival higher than 80 This improved survival is associated with major challenges for clinicians as most patients remain with limited exercise capacity and poor quality of life A clear understanding of exercise physiopathology is thus mandatory to specifically address mechanisms responsible for this exercise limitation and eventually improve patients management
In order to better characterize the exercise physiopathology in PAH the general objective of this research is to systematically examine blood flow distribution and limb muscles microcirculation at rest and during submaximal exercise in PAH The limited link between traditional measures of pulmonary hemodynamic impairment and functional capacity confirms that exercise physiopathology in PAH is not well understood Although peripheral muscle dysfunction and exercise intolerance are certainly multifactorial in origin and are unlikely to be explained by a single mechanism an altered skeletal muscle microcirculation could represent a unifying mechanism to explain similarities in skeletal muscle dysfunction and exercise intolerance in PAH The investigators plan to use a multimodality approach to provide comprehensive information regarding skeletal muscle perfusion in PAH For example the investigators will be able to know if there is some relationship between muscle perfusion heterogeneity arterial spin labeling MRI and microvascular oxygenation or muscle oxygen consumption NIRS Muscle oxygen delivery could also be influenced by cardiac function or hypoxemia These methods should thus be viewed as complimentary and will help to separate differences in cardiac function quadriceps global perfusion perfusion heterogeneity and oxygenation and their consequences on skeletal muscle function and exercise tolerance in PAH versus controls
In order to better characterize the exercise physiopathology in PAH the general objective of this research is to systematically examine blood flow distribution and limb muscles microcirculation at rest and during submaximal exercise in PAH The limited link between traditional measures of pulmonary hemodynamic impairment and functional capacity confirms that exercise physiopathology in PAH is not well understood Although peripheral muscle dysfunction and exercise intolerance are certainly multifactorial in origin and are unlikely to be explained by a single mechanism an altered skeletal muscle microcirculation could represent a unifying mechanism to explain similarities in skeletal muscle dysfunction and exercise intolerance in PAH The investigators plan to use a multimodality approach to provide comprehensive information regarding skeletal muscle perfusion in PAH For example the investigators will be able to know if there is some relationship between muscle perfusion heterogeneity arterial spin labeling MRI and microvascular oxygenation or muscle oxygen consumption NIRS Muscle oxygen delivery could also be influenced by cardiac function or hypoxemia These methods should thus be viewed as complimentary and will help to separate differences in cardiac function quadriceps global perfusion perfusion heterogeneity and oxygenation and their consequences on skeletal muscle function and exercise tolerance in PAH versus controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None