Clinical Trial

Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

Completed
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Summary
The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with CpcPH with elevated pulmonary vascular resistance (PVR equals or more than 4 WU). The main question it aims to answer is: • Can tadalafil improve patients with group II pulmonary hypertension with CpcPH, regarding functional, clinical, biomarker and echocardiographic outcomes? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria of CpcPH, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with the control group.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-05
critical Primary endpoint(s) modified 2026-08-05
notable Enrollment increased: 48 -> 66 participants 2026-08-05
notable Primary completion pushed: 2025-12-30 -> 2026-02-27 2026-08-05
Trial Details
NCT Number NCT06350773
Lead Sponsor Beni-Suef University
Conditions Group 2 Pulmonary Hypertension, CpcPH
Enrollment 66 participants
Start Date 2023-03-10
Primary Completion 2025-10-25 (estimated)
Study Completion 2025-10-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-11