Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06350773
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beni-Suef University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yasser Ahmed Abdelhady, Doctorate
Principal Investigator Affiliation	Beni-Suef University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Group 2 Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

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