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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Patients will receive tadalafil for 12 week follow up period, in addition to the conventional anti failure therapy.
Beni Suef University
Cairo, Beni Suweif Governorate, Egypt
Functional capacity of the patients
Six minute walk test, to assess the number of meters the patient can walk within 6 minutes, in be measured in meter unit.
Time frame: 12 weeks
heart failure symptoms
using NYHA classification either 1, 2, 3 or 4
Time frame: 12 weeks
right ventricular function
using Echocardiography, by measuring * RV diameters (basal, mid cavity and longitudinal) in mm * Transannular plane systolic excursion (TAPSE) in mm.
Time frame: 12 weeks
right ventricular function
* Fractional area change (FAC) in percentage. * RV strain in percentage.
Time frame: 12 weeks
right ventricular function
\- Tricuspid regurgitation severity by measuring jet area in cm2.
Time frame: 12 weeks
right ventricular function
using Echocardiography, by measuring pulmonary artery systolic pressure in mmHg.
Time frame: 12 weeks
right ventricular function
using Echocardiography, by measuring right ventricular systolic and diastolic velocities in cm/sec.
Time frame: 12 weeks
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