Pulmonary Arterial Hypertension
Conditions
Interventions
2.5 mg DDCI-01 group:receive oral 2.5 mg DDCI-01 capsule once daily for 12 consecutive weeks
10 mg DDCI-01 group:receive oral 10 mg DDCI-01 capsule once daily for 12 consecutive weeks
20 mg DDCI-01 group:receive oral 20 mg DDCI-01 capsule once daily for 12 consecutive weeks
tadalafil group:receive oral tadalafil (20 mg once daily, increased to 40 mg after 4 weeks) for 12 weeks
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old (inclusive), male or female; 2. Voluntarily participate and sign the informed consent form; 3. Subjects who are willing and able to comply with the research plan, laboratory tests and other research process requirements; 4. According to the Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension 2018, one of the following types of pulmonary hypertension (PAH) in the clinical classification of pulmonary hypertension (PH): a) Idiopathic pulmonary hypertension (IPAH) b) Hereditary pulmonary hypertension (HPAH) c) Drug- and toxicant-related pulmonary hypertension d) Pulmonary hypertension associated with any of the following: i. connective tissue disease, inflammation is well controlled, and the condition is stable; ii. Congenital heart disease with simple circulatory-pulmonary circulatory shunt and at least one year after surgical repair; 5. Confirmed hemodynamics of pulmonary hypertension by right heart catheterization (RHC) prior to randomization meeting all of the following criteria: a) Mean pulmonary artery pressure (mPAP) at rest>=25mmHg b) Pulmonary arteriolar wedge pressure (PAWP) at rest 3Wood units 6. WHO cardiac function grade II, III; 7. If receiving basic therapy for PAH, including but not limited to anticoagulants, diuretics, digoxin, and oxygen therapy, must be on a stable dose with no change within 2 weeks prior to randomization; 8. Patients who have not received pulmonary hypertension-targeted drugs within 4 weeks prior to randomization (including endothelin receptor antagonists, phosphodiesterase inhibitors, guanylate cyclase agonists, prostacyclin analogues, prostacyclin receptor agonists); 9. Able to take effective contraceptive measures during the trial and within 3 months after the end of the trial
Exclusion criteria
Exclusion criteria: 1. Patients with PH who belong to category 2~5 of the clinical classification of PH, as well as patients with other types of PAH in category 1 not covered by the inclusion criteria; 2. Pulmonary function test results meet any of the following: a) Forced expiratory volume in the first second (FEV1) 1.5 times ULN) or potential bleeding risk; 5. Abnormal liver function tests with the following criteria: serum total bilirubin >3 times ULN, alanine aminotransferase (ALT) >2.5 times ULN or aspartate aminotransferase (AST) >2.5 times ULN; 6. Abnormal renal function tests, meeting the following criteria: serum creatinine >2 times ULN; 7. Patients with severe left heart dysfunction; 8. Systolic blood pressure (SBP) 450msec in male subjects and QTc>470msec in female subjects; 10. Within 3 months prior to the screening period and/or planning to start an exercise-based cardiopulmonary rehabilitation program during the study; 11. History of alcohol abuse or drug abuse within 3 months prior to screening; 12. Body weight< 40kg; 13. Subjects who participated in and took other clinical trial drugs 1 month before the screening period; 14. Subjects who have any conditions that affect compliance with the study protocol or receive long-term floating catheter monitoring, and are judged by clinicians to be unsuitable for participating in this trial; 15. Those who meet any of the following criteria for infectious disease screening: a) Active hepatitis B virus infection (subjects who are positive for hepatitis B surface antigen [HBsAg] or positive for hepatitis B core antibody [HBcAb], if HBV-DNA is below the upper limit of normal and ALT and AST are normal, can be enrolled) b) Hepatitis C virus infection (defined as HCV antibody positive) c) Individuals with human immunodeficiency virus infection (defined as HIV antibody positive) d) Syphilis infected (defined as Treponema pallidum antibody positive) 16. In addition to the study diseases, other diseases such as digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, etc., or clinically significant examination abnormalities, which may interfere with the subject's participation in this clinical trial as judged by the investigator; 17. History of malignant tumors within 2 years prior to screening, except for cured basal cell or squamous cell carcinoma of the skin; 18. Pregnant or lactating women, or those who have a positive pregnancy test; 19. Allergic symptoms or history of allergy to the active ingredients or excipients of the study drug; 20. Those who have metal substances in the body (such as pacemakers, metal hemostats, implanted cochlear implants, etc.) or other contraindications that are not suitable for magnetic resonance examination; 21. Other circumstances that the investigator judges are not suitable for entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemodynamic parameters;hemodynamic parameters;hemodynamic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| N-terminal pro-B type natriuretic peptide;6-minute-walk-distance;emPHasis-10 Quality of Life Score;Borg Dyspnea Scale; | — |
Countries
China
Contacts
Public ContactZhicheng Jing
Guangdong Provincial People's Hospital
Outcome results
None listed