Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-009542
NCT ID: NCT04787445
About this study
The purpose of this study is to characterize the clinical and hemodynamic response of PAH therapy in patients with atypical PAH and risk factors for left heart disease.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years of age.
- Precapillary pulmonary hypertension with mean PA pressure > 20 mmHg and 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/m^2, 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yogesh Reddy, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available