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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tadalafil-receiving arm | Active Comparator | Patients will take tadalafil for the 12 week period of follow up, in addition to the standard evidence-based therapy for the left heart disease. |
|
| Tadalafil non-receiving arm | No Intervention | Patients will not take tadalafil for the 12 weeks follow up, only standard evidence-based therapy for the left heart disease. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil 20 mg then 40 mg if tolerated | Drug | Patients will receive tadalafil for 12 week follow up period, in addition to the conventional anti failure therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| heart failure symptoms | using NYHA classification either 1, 2, 3 or 4 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| right ventricular function | using Echocardiography, by measuring
| 12 weeks |
| right ventricular function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Ahmed Abdelhady, Doctorate | Beni-Suef University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni Suef University | Cairo | Beni Suweif Governorate | 62511 | Egypt |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 12 weeks |
| right ventricular function | - Tricuspid regurgitation severity by measuring jet area in cm2. | 12 weeks |
| right ventricular function | using Echocardiography, by measuring pulmonary artery systolic pressure in mmHg. | 12 weeks |
| right ventricular function | using Echocardiography, by measuring right ventricular systolic and diastolic velocities in cm/sec. | 12 weeks |
| D002318 |
| Cardiovascular Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |