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A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Sildenafil in the Treatment of Patients With Pulmonary Hypertension Associated to Chronic Obstructive Lung Disease
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Pulmonary Unit - Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, Milano, Italy
Pulmonary Diseases Clinic - Azienda Ospedaliera Universitaria - Policlinico di Modena
Modena, Modena, Italy
Pulmonary Clinic - Federico II University - Azienda Ospedaliera V. Monaldi
Naples, Napoli, Italy
Thoracic Surgery Clinic - Azienda Ospedaliera di Padova
Padua, Padova, Italy
Dept. of Medicine - Pulmonary Medicine - IsMeTT
Palermo, Palermo, Italy
Pulmonary Diseases Clinic - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
Pulmonary Hypertension Center - Policlinico Umberto I
Rome, Rome, Italy
University Pulmonary Unit - Azienda Ospedaliera Universitaria Senese
Siena, Siena, Italy
Pulmonary Unit - Azienda Ospedaliera Universitaria San Giovanni Battista
Torino, Torino, Italy
Pulmonary Unit - Azienda Ospedaliera Universitaria Ospedali Riuniti di Trieste
Trieste, Trieste, Italy
Start Date
October 1, 2010
Primary Completion Date
February 1, 2013
Completion Date
February 1, 2013
Last Updated
February 4, 2013
32
ESTIMATED participants
Sildenafil citrate
DRUG
Sugar pills
DRUG
Lead Sponsor
Italian Association of Hospital Pneumologists
NCT07073820
NCT07477600
NCT06899815
Data Source & Attribution
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