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Clinic investigation on pulmonary artery hypertension associated with connective tissue disease

Randomized double-blind placebo controlled clinic trial on patients with CTD-PAN with combined targeted therapy in early stage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009511
Enrollment
Unknown
Registered
2016-10-20
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary artery hypertension associated with connective tissue disease

Interventions

A:Placebo of Bosentan and Sildenafil
B:Sildenafil and placebo of Bosentan
C:Bosentan and placebo of Sildenafil
D:Bosentan and Sildenafil

Sponsors

Ren Ji Hospital, School of medecine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: All newly onset connective tissue disease patients aged 15 to 75 with MPAP=25mmHg and PCWP=15mmHg diagnosed by right heart catheter

Exclusion criteria

Exclusion criteria: 1. SaO242mm, LV>56mm, IVS>11mm, stenosis or at least moderate regurgitation of mitral and aortic valve; LVEF221umol/L, liver fuction at least three times higher than normal value; 5. Uncontrolled hypertension: SBP>160mmHg, DBP>100mmHg; 6. Ischemic cardiomyopathy and history of AMI within 6 months; 7. Other causes of PAH, such as portal hypertension, CTEPH, PVOD; 8. OSAS.

Design outcomes

Primary

MeasureTime frame
6-MWD;Clinic events;—

Secondary

MeasureTime frame
Hemodynamic parameter such as pulmonary vascular resistance;—

Countries

China

Contacts

Public ContactShen Jieyan

Ren Ji Hospital, School of medecine, Shanghai Jiao Tong University

dr_jyshen@sina.cn+86 13701864819

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026