Status:
COMPLETED
Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension
Lead Sponsor:
Mayo Clinic
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
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 diseas...
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 factor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04787445
Start Date
March 11 2021
End Date
November 21 2023
Last Update
March 21 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905