NCT06350773

Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is: • Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, 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 another age- and sex- matched control placebo group.

Detailed description

The study aims at studying the efficacy of tadalafil in patients with group 2 pulmonary hypertension with elevated pulmonary vascular resistance guided by RHC. After fulfilling the inclusion criteria, investigators will recruit 48 patients, and do baseline echocardiography for comprehensive right ventricular (RV) study and 6 minute walk test, and then start tadalafil 20 mg then 4mg if tolerated, for 24 patients (drug group). After three months follow up, investigators will follow up the patients regarding RV function and the functional capacity, compared to matched control group.

Conditions

• Group 2 Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	tadalafil 20 mg then 40 mg if tolerated	Patients will receive tadalafil for 12 week follow up period, in addition to the conventional anti failure therapy.

Timeline

• Start date: 2023-06-10
• Primary completion: 2025-12-30
• Completion: 2026-06-01
• First posted: 2024-04-05
• Last updated: 2026-03-09

Locations

1 site across 1 country: Egypt