Pulmonary Arterial Hypertension (PAH)
Conditions
Brief summary
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
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.
Interventions
DEVICEMagnetic Resonance Imaging (MRI) with exercise
MRI scan with a novel exercise device.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single center, open label, single-arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of pulmonary arterial hypertension or a subtype 2. Referred for right heart catheterization 3. Age between 18 and 80 years 4. New York Heart Association (NYHA) functional class I, II, or III
Exclusion criteria
1. Recent syncope (within 1 year) 2. Severe skeletal or muscle abnormalities prohibiting exercise 3. Mixed etiology pulmonary arterial hypertension 4. Severe lung disease 1. Test results indicating severe obstruction 2. Total lung capacity \< 60% 5. Pregnancy or breastfeeding 6. NYHA class IV patient 7. Contraindications to magnetic resonance imaging 8. Kidney dysfunction as determined by an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73m2 9. Contraindication to gadolinium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging. | Up to 24 months | 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. |
Outcome results
None listed