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

Chinese Academy of Medical Sciences, Fuwai Hospital46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COPD Pulmonary Hypertension

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pulmonary artery pressure

pressure in mmHg

Time frame: 12 weeks

pulmonary vascular resistance

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