Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

NCT06350773 | Active Not Recruiting

• 1 other identifier: FMBSUREC/06122022/ Zaher
• Study Type: interventional
• Target: 48
• 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 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.

Conditions

Group 2 Pulmonary Hypertension

Keywords

PDEI; pulmonary hypertension; pulmonary vascular resistance; right heart catheterization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• right ventricular function

  12 weeks

• right ventricular function

  12 weeks

• right ventricular function

  12 weeks

• right ventricular function

  12 weeks

• right ventricular function

  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, in addition to the conventional anti failure therapy.

tadalafil-receiving arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University

Cairo, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

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: June 10, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)