The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD

Not Applicable

• Conditions: Pulmonary Hypertension; COPD
• Interventions: Drug: Placebo Oral Tablet; Drug: Sildenafil Citrate

• Registration Number: NCT03185364
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-11
• Last Update Submitted: 2017-06-11
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Study Start: 2017-06-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Stable for over 1 month
• mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
• never received target therapy before

Exclusion Criteria

• Patients with other serious respiratory diseases
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo Oral Tablet	placebo oral tablet, 12 weeks
Interventional group	Sildenafil Citrate	Sildenafil Citrate, 20mg, tid for 12 weeks

Primary Outcome Measures

Name	Time	Method
pulmonary artery pressure	12 weeks	pressure in mmHg
pulmonary vascular resistance	12 weeks	woods

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China