Status:
UNKNOWN
Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
Magdi H. Yacoub
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In a group of patients with PAH treated with treprostinil, the current study aims to investigate the effect of treatment on RV structure and function; and correlate changes in RV structure and functio...
Detailed Description
A) Right ventricle (RV) in pulmonary hypertension RV failure is the main cause of death in patients with pulmonary arterial hypertension (PAH), and the ability of the RV to adapt to the progressive i...
Eligibility Criteria
Inclusion
- PAH defined as a mean pulmonary artery pressure \>25 mmHg on right heart catheterization at rest in the setting of a normal pulmonary arterial wedge pressure ≤15 mm Hg
- PAH that is idiopathic, familial, or associated with connective tissue disease.
- WHO class III or class IV despite the use of Endothelin receptor antagonists (ERA) and/or phosphodiesterase-5 inhibitors
- Age \> 18 years
- Sinus rhythm
Exclusion
- Patients with PAH associated with HIV infection, portal hypertension, congenital heart disease, schistosomiasis, chronic haemolytic anaemia
- Patients with pulmonary hypertension due to veno-occlusive disease and/or pulmonarycapillary haemangiomatosis, thromboembolism.
- Patients with left side heart disease that may contribute to pulmonary hypertension. Those patients are identified by having pulmonary wedge pressure \>15 mmHg or elevated Left Ventricle (LV) end-diastolic pressure
- Patients who are severely disabled and will not be able to complete the study
- Patients with significant lung disease as shown by forced vital capacity (FVC) \< 70% predicted, or forced expiratory volume at one second (FEV1)/FVC \< 50% - Life expectancy \<1 year due to severe PAH or any other forms of terminal disease.
- Pregnant women
- Refusal to give informed consent.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03835676
Start Date
May 1 2019
End Date
December 1 2025
Last Update
December 15 2022
Active Locations (1)
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1
Aswan Heart Centre - Magdi Yacoub Heart Foundation
Aswān, Egypt