NCT06350773Completed
Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension
The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 19 Mar 2024
- Start date
- 10 Mar 2023
- Primary completion date
- 25 Oct 2025
- Lead sponsor
- Beni-Suef University
- NCT number
- NCT06350773
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 10 Mar 2023 to the primary completion date, 25 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to PDE-5 inhibitors, including current nitrate therapy.
- Current enrollment, or enrollment completed \<30 days previously, in another investigational drug or device clinical study.
Other illness
- Hypersensitivity, allergy, or intolerable side effects of PDE-5 inhibitors.
- Anticipated cardiac resynchronization therapy within 3 months of enrollment.
- History of heart transplant, ventricular-assist device, or any other solid-organ transplant
- Recent stroke, myocardial infarction, any coronary intervention; PCI or CABG.
- Decompensated heart failure.
- Undergoing dialysis for end-stage renal disease.
- End-stage liver disease comorbidities, limiting exercise tolerance.
- Severe peripheral vascular disease with intermittent claudication.
- Severe degenerative joint disease preventing normal walking.
Other
- 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).
- 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)
- Morbid obesity (body mass index \> 40).
- Status after amputation of lower extremity(s) at any level.
- Cerebrovascular accident with long-term sequelae affecting ability to walk.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beni Suef University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.