Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

Study Overview
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Brief Summary
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The goals of this study were two-fold. First, the attempt to quantify the relationships between pulmonary arterial stiffness, right ventricular function and the efficiency of ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH). Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness, pulmonary vascular resistance, right ventricular function and the efficiency of ventricular-vascular interactions in patients with PAH.

Detailed Description
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The goals of this study are to quantify right ventricular-pulmonary vascular interactions in different types of PAH, to determine the temporal changes in these interactions with PAH progression and to quantify the effects of exercise on right ventricular function. The inclusion of the subpopulation of PAH patients with systemic sclerosis (SSc) was a result of the anticipation that this group has worse arterial stiffening than other groups, and consequently more inefficient right ventricular-pulmonary vascular interactions, which account for their worse prognosis.

Official Title
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Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

Conditions
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Pulmonary Arterial Hypertension (PAH)

Intervention / Treatment
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* Device: Magnetic Resonance Imaging (MRI) with exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of pulmonary arterial hypertension or a subtype Referred for right heart catheterization Age between 18 and 80 years New York Heart Association (NYHA) functional class I, II, or III Exclusion Criteria: Recent syncope (within 1 year) Severe skeletal or muscle abnormalities prohibiting exercise Mixed etiology pulmonary arterial hypertension Severe lung disease Test results indicating severe obstruction Total lung capacity < 60% Pregnancy or breastfeeding NYHA class IV patient Contraindications to magnetic resonance imaging Kidney dysfunction as determined by an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73m2 Contraindication to gadolinium

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single center, open label, single-arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>A research MRI scan with exercise will be obtained in conjunction with standard of care cardiopulmonary testing. | Device: Magnetic Resonance Imaging (MRI) with exercise<br>* MRI scan with a novel exercise device.<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging. | The hypotheses will be tested by comprehensively quantifying ventricular and vascular function in subjects with idiopathic pulmonary arterial hypertension, systemic sclerosis pulmonary arterial hypertension, and chronic thromboembolic pulmonary hypertension, using investigational magnetic resonance angiography techniques. | Up to 24 months |