The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
NCT ID: NCT03185364
Last Updated: 2017-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2017-06-15
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Interventional group
Sildenafil Citrate, 20mg, tid for 12 weeks
Sildenafil Citrate
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
Control group
placebo oral tablet, 12 weeks
Placebo Oral Tablet
placebos treatment for 12 weeks
Interventions
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Sildenafil Citrate
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
Placebo Oral Tablet
placebos treatment for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
* never received target therapy before
Exclusion Criteria
* Patients with pulmonary hypertension other than group 3
* Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
* Patients with limited life expectancy
* Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
* Psychopath or addict
* Nonstable patients with type Ⅰor Ⅱ respiratory failure
* Patients with contraindication for sildenafil
* Patients in pregnancy or breastfeeding
40 Years
85 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Jianguo He
Chief of Pulmonary Vascular Disease Center
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Facility Contacts
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Role: backup
Other Identifiers
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2016YFC1304401B
Identifier Type: -
Identifier Source: org_study_id
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