Pulmonary Hypertension
Conditions
Interventions
TMP group:The routine therapy with TMP 100mg po t.i.d
Sponsors
State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the creteria of mean pulmonary arterial pressure (mPAP) higher than 20 mmHg at seal level at rest and with the pulmonary capillary wedge pressure (PCWP) lower than 15mmHg; 2. Category of 1,3 or 4 of PH in stable stage according to 2013 Nice (France) Conference,including the idiopathic, hereditary, drugs and toxins induced, associated with connective tissue diseases or congenital heart diseases, COPD, interstitial lung diseases,other restrictive or/and obstructive diseases, PH induced by long-time residence on the plateau, and chronic thromboembolic pulmonary arterial hypertension(PAH); 3. Male or female aged 15 to 70 years old; 4. WHO pulmonary hypertension functional class II, III or IV; 5. The baseline of 6-minute walk distance between 100-450 m; 6. Patients' status should be stable for at least one month after basic treatment; For those with congenital heart diseases, surgery should have been performed six months or more before they are enrolled in the study; 7. Patients or their guardians should agree with this clinical trail and sign the medical informed consent.
Exclusion criteria
Exclusion criteria: 1. Unavailable or limited legal capacity; 2. Pregnant or lactational women; 3. Important organs with severe diseases; 4. Mental or physical disability; 5. With suspected or definite alcohol, drug abuse history; 6. Allergic to any component of the experimental drug; 7. Patients with IPAH responding to acute pulmonary vasodilator testing; 8. With both aspartate aminotransferase (AST) and glutamic-pyruvic transaminase (ALT) more than three times of the upper limit of normal in liver function test and Ccr less than 50ml/min in kidney function test; 9. Those with systemic blood pressure lower than 90/50 mmHg, or those uncontrolled dangerous hypertension(BP higher than 170/110 mmHg); 10. Stop or change drug(s) targeting PH in the less than 3 months; 11. Patients at active stages of infectious or other diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and some connective tissue diseases; 12. Patients with severe infection, especially pulmonary infection; 13. Patients with shock or astable hemodynamics with other causes; 14. Patients with hepatic cirrhosis, and hepatic cirrhosis induced portal hypertension; 15. Patients with severe hemorrhage, and hemorrhagic tendency; 16. Patients cannot accomplish required items (especially 6MWD) because of acute/chronic organic disease (excluding dyspnea) or other illnesses such as lower extremity diseases; 17. Patients with any other conditions considered cannot be recruited.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walking distance;Heart rate recovery in 1 second; | — |
Secondary
| Measure | Time frame |
|---|---|
| WHO functional class of pulmonary hypertension(PH);Borg dyspnea score;Minnesota living with heart failure questionnaire;BNP in blood plasm;Right ventricular systolic pressure evaluated by echocardiography;Cardiac index;Oxygen saturation in arterial blood; | — |
Countries
China
Contacts
Public ContactJian Wang
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed