Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Group 2 Pulmonary Hypertension
• Intervention / Treatment: Drug: tadalafil 20 mg then 40 mg if tolerated

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Cairo, Beni Suweif Governorate, Egypt, 62511
      • Beni suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
right ventricular function	using Echocardiography, by measuring; RV diameters (basal, mid cavity and longitudinal) in mm; Transannular plane systolic excursion (TAPSE) in mm.	12 weeks
right ventricular function	Fractional area change (FAC) in percentage.; RV strain in percentage.	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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Study Director: Yasser Ahmed Abdelhady, Doctorate, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): December 30, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pulmonary hypertension; right heart catheterization; pulmonary vascular resistance; PDEI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indole Alkaloids; Heterocyclic Compounds, 3-Ring; Carbolines; Tadalafil
• Other Study ID Numbers: FMBSUREC/06122022/ Zaher

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No