Testing tadalafil for patients with group 2 pulmonary hypertension

The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension

This study is testing if tadalafil can help people with group 2 pulmonary hypertension feel better and improve their heart function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beni-Suef University (Academic / other)
• Locations: 1 site (Cairo, Beni Suef)
• Trial ID: NCT06350773 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of tadalafil in patients diagnosed with group 2 pulmonary hypertension who have elevated pulmonary vascular resistance. Participants will undergo right heart catheterization to confirm eligibility and will be treated with tadalafil, starting at 20 mg and potentially increasing to 40 mg over a 12-week period. The study will include a control group matched by age and sex to compare outcomes related to right ventricular function and functional capacity. Follow-up assessments will be conducted to determine the drug's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are patients with group 2 pulmonary hypertension and elevated pulmonary vascular resistance who have been on heart failure medical therapy for at least 90 days prior to enrollment.

Not a fit: Patients with contraindications to PDE-5 inhibitors or those with other forms of pulmonary hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the quality of life and functional capacity for patients suffering from group 2 pulmonary hypertension.

How similar studies have performed: While the use of PDE-5 inhibitors in pulmonary hypertension has been explored, this specific application in group 2 pulmonary hypertension is less common and may represent a novel approach.

Eligibility criteria

Inclusion Criteria:

* group 2 pulmonary hypertension with precapillary component with PVR more than 4 by RHC
* Patients should be on HF medical therapy 90 days before enrollment in the study.

Exclusion Criteria:

* Anticipated cardiac resynchronization therapy within 3 months of enrollment.
* Hypersensitivity, allergy, or intolerable side effects of PDE-5 inhibitors.
* Contraindication to PDE-5 inhibitors, including current nitrate therapy.
* All groups of PH, other than group 2 PH (isolated post capillary pulmonary hypertension).
* History of heart transplant, ventricular-assist device, or any other solid-organ transplant
* Likely to have solid-organ transplant or any other major surgery during study enrollment/treatment period.
* 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.

Where this trial is running

Cairo, Beni Suef

• Beni Suef University — Cairo, Beni Suef, Egypt (Recruiting)

Study contacts

• Study coordinator: Marina Awad Zaher, Master

Conditions Group 2 Pulmonary Hypertension; PDEI; pulmonary hypertension; pulmonary vascular resistance; right heart catheterization