Skip to content

A randomized controlled trial of targeted drugs for pulmonary hypertension in the treatment of pulmonary hypertension caused by fibrous mediastinitis

Study on the safety and efficacy of pulmonary hypertension targeted drugs in the treatment of pulmonary hypertension caused by fibrous mediastinitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034808
Enrollment
Unknown
Registered
2020-07-20
Start date
2020-07-22
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Fibrosing mediastinitis

Interventions

Experimental group:Ambesentan
Control group:Placebo

Sponsors

Gansu Provincial Peolie's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Right heart catheterization examination within 3 months before admission: mean pulmonary artery pressure >= 25 mmHg, pulmonary vascular resistance > 3 wood, pulmonary artery wedge pressure or left ventricular end diastolic pressure <= 15 mmHg; 2. Patients diagnosed as fibromediastinitis by CT pulmonary angiography; 3. Patients with baseline 6MWD between 150-450m; 4. WHO FC grade II or III patients; 5. The forced expiratory volume per second (FEV1) of patients with total vital capacity greater than or equal to 60% of the predicted normal value was greater than or equal to 55% of the predicted normal value; 6. Patients with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients younger than 18 years old or over 75 years old; 2. Patients with moderate or severe valvular disease, pericardial constriction, restrictive or congestive cardiomyopathy, life-threatening arrhythmia, left ventricular ejection fraction 2 times ULN, serum bilirubin > 1.5 times ULN; 15. Patients with drug allergy or intolerable adverse reactions.

Design outcomes

Primary

MeasureTime frame
6-minute walk distance;WHO functional classification;

Secondary

MeasureTime frame
NT-proBNP;

Countries

China

Contacts

Public ContactCao Yunshan

Gansu Provincial Hospital

yunshancao@126.com+86 13669306699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026