Effects of Treprostinil on Right Ventricular Function in Pulmonary Hypertension
Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension
This study tests if treprostinil can improve how the right side of the heart works in people with pulmonary arterial hypertension and if these changes can lead to better overall health and quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Magdi Yacoub Heart Foundation Academic / other |
| Locations | 1 site (Aswan) |
| Trial ID | NCT03835676 on ClinicalTrials.gov |
What this trial studies
This study investigates how treprostinil treatment affects the structure and function of the right ventricle in patients with pulmonary arterial hypertension (PAH). It aims to correlate changes in right ventricular function with clinical measures such as WHO classification, six-minute walk test results, quality of life assessments, and specific biomarkers. The study focuses on understanding the mechanisms of right ventricular failure in PAH and how treatment can improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with idiopathic or connective tissue disease-associated PAH who are classified as WHO class III or IV despite existing treatments.
Not a fit: Patients with pulmonary hypertension due to left heart disease or other specific conditions like HIV infection or congenital heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for patients with pulmonary arterial hypertension.
How similar studies have performed: Other studies have shown promising results with treprostinil in improving right ventricular function in PAH, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Aswan
- Aswan Heart Centre - Magdi Yacoub Heart Foundation — Aswan, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed M ElGuindy, MD, MRCP
- Email: ahmed_elguindy@hotmail.com
- Phone: +201001615151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.