Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

NCT06350773 | Completed

• 1 other identifier: FMBSUREC/06122022/ Zaher
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

CpcPH; Group 2 Pulmonary Hypertension

Keywords

PDEI; pulmonary vascular resistance; right heart catheterization; CpcPH

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• Functional capacity

  using NYHA classification either 1, 2, 3 or 4

  12 weeks

Secondary Outcomes (9)

• Risk profile assessment

  12 weeks

• Rate of hospitalization

  12 weeks

• Right ventricular size

  12 weeks

• Right ventricular function

  12 weeks

• Pulmonary artery pressure

  12 weeks

Study Arms (2)

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.

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.

Interventions

tadalafil 20 mg then 40 mg if tolerated DRUG

Patients will receive tadalafil for 12 week follow up period

tadalafil-receiving arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University

Cairo, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Interventions

Tadalafil

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Yasser Ahmed Abdelhady, Doctorate

  Beni-Suef University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 5, 2024
• Study Start: March 10, 2023
• Primary Completion: October 25, 2025
• Study Completion: October 25, 2025
• Last Updated: August 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)