Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350773
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-19
Brief Title:
Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None