SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD
Status:
Unknown status
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary
diseases, and it is an independent prognostic factor, until now no evidence-based treatment
approach exists for those patients.
This study will address if the drug sildenafil can lower pulmonary vascular resistance in
patients with significant pulmonary hypertension (high blood pressure in the lungs)
associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment can
improve effort capacity, quality of life without causing a deterioration in pulmonary gas
exchange (mainly arterial oxygenation).
Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean
pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are
randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks.
Before starting treatment (baseline), and a the end of the study, the patients have a
comprehensive assessment including:
- a chest x-ray and CT scan (only at baseline);
- pulmonary function tests to measure how much air the patient can breathe in and out, and
the capacity of diffusion of gases;
- arterial blood gases analysis (for safety reason this examination is performed at
baseline, before the randomization after one hour from the administration of a tablet
(20 mg) of sildenafil, and every month)
- an echocardiogram (heart ultrasound) (only at baseline);
- a 6-minute walk test to measure exercise capacity;
- a quality-of-life assessment (SF-36 questionnaire)
- a right heart catheterization to evaluate the severity of hypertension
At the end of the 16-week period, patients may opt to continue to receive sildenafil and
monitoring in an open-label phase of the study for up to 1 year.