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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: COPD; Pulmonary Hypertension

Treatments: Drug: Sildenafil Citrate; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03185364

2016YFC1304401B

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Interventional group

Experimental group

Description:

Sildenafil Citrate, 20mg, tid for 12 weeks

Treatment:

Drug: Sildenafil Citrate

Control group

Placebo Comparator group

Description:

placebo oral tablet, 12 weeks

Treatment:

Drug: Placebo Oral Tablet