Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

NCT ID: NCT06350773

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2026-02-28

Brief Summary

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tadalafil-receiving arm

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.

Group Type: ACTIVE_COMPARATOR

tadalafil 20 mg then 40 mg if tolerated

Intervention Type: DRUG

Patients will receive tadalafil for 12 week follow up period, in addition to the conventional anti failure therapy.

Tadalafil non-receiving arm

Patients will not take tadalafil for the 12 weeks follow up, only standard evidence-based therapy for the left heart disease.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tadalafil 20 mg then 40 mg if tolerated

Patients will receive tadalafil for 12 week follow up period, in addition to the conventional anti failure therapy.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Marina Awad

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser Ahmed Abdelhady, Doctorate

Role: STUDY_DIRECTOR

Beni-Suef University

Locations

Beni Suef University

Cairo, Beni Suweif Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marina Awad Zaher, Master

Role: CONTACT

Marinaawad984@gmail.com

201271159549

Facility Contacts

Hesham Boshra Mahmoud, Doctorate

Role: primary

heshamboshra@gmail.com

201001402250

Other Identifiers

FMBSUREC/06122022/ Zaher

Identifier Type: -

Identifier Source: org_study_id