CpcPH, Group 2 Pulmonary Hypertension
Conditions
Keywords
PDEI, pulmonary vascular resistance, right heart catheterization, CpcPH
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.
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.
Interventions
DRUGtadalafil 20 mg then 40 mg if tolerated
Patients will receive tadalafil for 12 week follow up period
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity | 12 weeks | Six minute walk test, to assess the number of meters the patient can walk within 6 minutes, in be measured in meter unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk profile assessment | 12 weeks | Risk assessment by ESC/ERS multiparametric model, expressed as risk category (low, intermediate or high). |
| Rate of hospitalization | 12 weeks | Rate of Heart failure- related hospitalization |
| Right ventricular size | 12 weeks | using Echocardiography, by measuring - RV diameters (basal, mid cavity and longitudinal) in mm. |
| Right ventricular function | 12 weeks | \- Fractional area change (FAC) by echocardiography, in percentage (%) Time Frame: 12 weeks |
| Pulmonary artery pressure | 12 weeks | Estimated pulmonary artery systolic pressure in mmHg (estimated from peak TR velocity, by echocardiography. |
| NT-proBNP | 12 weeks | NT-proBNP by ELISA, in pg/mL |
| Right-sided heart failure manifestations | 12 weeks | Peripheral edema grade (0 no edema to 4 severe edema) |
| Left ventricular diastolic function | 12 weeks | E/e' ratio using doppler and tissue doppler echocardiography |
| Left ventricular systolic function | 12 weeks | using modified simpsons method, by echocardiography, expressed in percentage (%) |
Countries
Egypt
Contacts
STUDY_DIRECTORYasser Ahmed Abdelhady, Doctorate
Beni-Suef University
Outcome results
None listed