COPD, Pulmonary Hypertension
Conditions
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.
Interventions
DRUGSildenafil Citrate
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
DRUGPlacebo Oral Tablet
placebos treatment for 12 weeks
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pulmonary artery pressure | 12 weeks | pressure in mmHg |
| pulmonary vascular resistance | 12 weeks | woods |
Countries
China
Outcome results
None listed