Pulmonary Arterial Hypertension
Conditions
Keywords
Right Heart Catheterization
Brief summary
The purpose of this study is to characterize the clinical and hemodynamic response of Pulmonary Arterial Hypertension (PAH) therapy in patients with atypical PAH and risk factors for left heart disease.
Detailed description
This is an observational prospective study to better understand the clinical impact of Pulmonary Arterial Hypertension (PAH) specific therapy in patients with atypical PAH among those with risk factors for left heart disease The study involves detailed baseline clinical evaluation prior to initiation of PAH therapy, followed by repeat clinical assessment after 6 months of medical therapy
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Pulmonary hypertension with mean PA pressure \>20 mmHg and a planned initiation of pulmonary arterial hypertension therapy * No active treatment for precapillary pulmonary hypertension * Ambulatory (not wheelchair/scooter dependent) * Presence of any risk factor for left heart disease will qualify for inclusion (either atrial fibrillation, body mass index\>30 kg/m2, arterial hypertension, diabetes, coronary artery disease or age\>60 years)
Exclusion criteria
* Significant chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator * Ischemia thought to contribute to dyspnea in the opinion of the investigator * Obstructive hypertrophic cardiomyopathy * Known infiltrative cardiomyopathy (amyloid) * Constrictive pericarditis or tamponade * Active myocarditis * Complex congenital heart disease * More than mild aortic or mitral stenosis * Intrinsic (prolapse, rheumatic) valve disease with more than moderate mitral, tricuspid or aortic regurgitation * Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR \> 1.7 in the absence of anticoagulation treatment * Terminal illness (other than HF) with expected survival of less than 1 year * Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months. * Inability to comply with planned study procedures * Pregnancy or breastfeeding mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe prevalence of occult left heart disease during exercise in atypical pulmonary hypertension, as defined by pulmonary arterial wedge pressure during exercise cardiac catheterization. | Baseline Catheterization | Pulmonary arterial wedge pressure \>25 mmHg during exercise cardiac catheterization will indicate occult left heart disease. |
| Evaluate the therapeutic response of chronic pulmonary vasodilator therapy | 6 Month Catheterization | Favorable pulmonary vasodilatory effect will be associated a change of \> 10% reduction in pulmonary artery-pressure flow slope from baseline to 6 month catheterization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Identify predictors on baseline exercise catheterization of subsequent exercise capacity improvement following chronic pulmonary vasodilatory therapy. | 6 Month Catheterization | From paired exercise capacity measurements of peak VO2 from baseline to 6 month testing, patients with clinically meaningful change defined by improvement following treatment of \>1 ml/kg/min will be identified. Measurements on baseline exercise catheterization, echocardiography, left atrial strain and clinical characteristics will be assessed for their ability to predict exercise capacity improvement by logistic regression. |
Countries
United States
Outcome results
None listed