Group 2 Pulmonary HypertensionNCT06350773
Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension
A study testing tadalafil 20 mg then 40 mg if tolerated in people with Group 2 Pulmonary Hypertension and CpcPH, run by Beni-Suef University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Group 2 Pulmonary Hypertension, CpcPH
- What is being tested?
- tadalafil 20 mg then 40 mg if tolerated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- group 2 pulmonary hypertension with CpcPH with PVR equals or more than 4 by RHC.
- NYHA II-III symptoms.
- Patients should be on HF medical therapy 90 days before enrollment in the study.
Who cannot join
- All groups of PH, other than Group 2 PH.
- Patients with Group 2, but no meeting the predefined hemodynamic criteria for CpcPH (mean PAP more than 20 mmHg, mean PCWP more than 15 mmHg, PVR equals or more than 4 WU).
- Hypersensitivity, allergy, or intolerable side effects of PDE-5 inhibitors.
- Contraindication to PDE-5 inhibitors, including current nitrate therapy.
- Anticipated cardiac resynchronization therapy within 3 months of enrollment.
- History of heart transplant, ventricular-assist device, or any other solid-organ transplant
Show all 18Show fewer
- Recent stroke, myocardial infarction, any coronary intervention; PCI or CABG.
- Decompensated heart failure.
- Female subject who is pregnant, breast-feeding, or unwilling to practice an acceptable method of birth control unless postmenopausal or sterile.
- Unreliability as a study participant, based on the investigator's (or designee's) knowledge of the subject (e.g., alcohol or other substance abuse, inability or unwillingness to adhere to the protocol, documented noncompliance, or vulnerable population)
- Current enrollment, or enrollment completed <30 days previously, in another investigational drug or device clinical study.
- Undergoing dialysis for end-stage renal disease.
- End-stage liver disease comorbidities, limiting exercise tolerance.
- Morbid obesity (body mass index > 40).
- Severe peripheral vascular disease with intermittent claudication.
- Status after amputation of lower extremity(s) at any level.
- Severe degenerative joint disease preventing normal walking.
- Cerebrovascular accident with long-term sequelae affecting ability to walk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension
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.
Read the 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, CpcPH
- Being tested
- tadalafil 20 mg then 40 mg if tolerated
- Keywords
- PDEI, pulmonary vascular resistance, right heart catheterization, CpcPH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafil 20 mg then 40 mg if toleratedDrug
Patients will receive tadalafil for 12 week follow up period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: tadalafil 20 mg then 40 mg if tolerated |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Six minute walk test, to assess the number of meters the patient can walk within 6 minutes, in be measured in meter unit.
Measured: 12 weeks
Functional capacity
using NYHA classification either 1, 2, 3 or 4
Measured: 12 weeks
Secondary outcomes (9)
Risk profile assessment
Risk assessment by ESC/ERS multiparametric model, expressed as risk category (low, intermediate or high).
Measured: 12 weeks
Rate of hospitalization
Rate of Heart failure- related hospitalization
Measured: 12 weeks
Right ventricular size
using Echocardiography, by measuring - RV diameters (basal, mid cavity and longitudinal) in mm.
Measured: 12 weeks
Right ventricular function
- Fractional area change (FAC) by echocardiography, in percentage (%) Time Frame: 12 weeks
Measured: 12 weeks
Pulmonary artery pressure
Estimated pulmonary artery systolic pressure in mmHg (estimated from peak TR velocity, by echocardiography.
Measured: 12 weeks
NT-proBNP
NT-proBNP by ELISA, in pg/mL
Measured: 12 weeks
Right-sided heart failure manifestations
Peripheral edema grade (0 no edema to 4 severe edema)
Measured: 12 weeks
Left ventricular diastolic function
E/e' ratio using doppler and tissue doppler echocardiography
Measured: 12 weeks
Left ventricular systolic function
using modified simpsons method, by echocardiography, expressed in percentage (%)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Mar 2023
- Primary completion25 Oct 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group 2 Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Awad, Beni-Suef University
- Investigators
- Yasser Ahmed Abdelhady, Doctorate, Study director, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350773
- Sponsor's protocol ID
- FMBSUREC/06122022/ Zaher
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06350773
- Acronym / sponsor ID
- FMBSUREC/06122022/ Zaher
- Conditions
- Group 2 Pulmonary Hypertension, CpcPH
- Keywords
- PDEI, pulmonary vascular resistance, right heart catheterization, CpcPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tadalafil-receiving arm | Active comparator | Drug: tadalafil 20 mg then 40 mg if toleratedPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- group 2 pulmonary hypertension with CpcPH with PVR equals or more than 4 by RHC.
- NYHA II-III symptoms.
- Patients should be on HF medical therapy 90 days before enrollment in the study.
Key exclusion criteria (18 listed)
- All groups of PH, other than Group 2 PH.
- Patients with Group 2, but no meeting the predefined hemodynamic criteria for CpcPH (mean PAP more than 20 mmHg, mean PCWP more than 15 mmHg, PVR equals or more than 4 WU).
- Hypersensitivity, allergy, or intolerable side effects of PDE-5 inhibitors.
- Contraindication to PDE-5 inhibitors, including current nitrate therapy.
- Anticipated cardiac resynchronization therapy within 3 months of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tadalafil 20 mg then 40 mg if toleratedPatients will receive tadalafil for 12 week follow up period | Drug | tadalafil-receiving arm |
Primary outcome
Functional capacity
Time frame: 12 weeks
Six minute walk test, to assess the number of meters the patient can walk within 6 minutes, in be measured in meter unit.
Functional capacity
Time frame: 12 weeks
using NYHA classification either 1, 2, 3 or 4
9 secondary outcomes
Risk profile assessment
Time frame: 12 weeks
Rate of hospitalization
Time frame: 12 weeks
Right ventricular size
Time frame: 12 weeks
Right ventricular function
Time frame: 12 weeks
Pulmonary artery pressure
Time frame: 12 weeks
NT-proBNP
Time frame: 12 weeks
Right-sided heart failure manifestations
Time frame: 12 weeks
Left ventricular diastolic function
Time frame: 12 weeks
Left ventricular systolic function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Ahmed Abdelhady, Doctorate study director
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tadalafil 20 mg then 40 mg if tolerated in people with Group 2 Pulmonary Hypertension and CpcPH, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.