Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.
In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.
Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.|
- 6 minute walk test [ Time Frame: at base line, after 2 hours and after 3 months ] [ Designated as safety issue: No ]
- assessment of life quality [ Time Frame: At baseline and follow up after three months ] [ Designated as safety issue: No ]
- Systolic pulmonary pressure [ Time Frame: At baseline and follow-up after three months ] [ Designated as safety issue: No ]
- Activity of symptoms measured by use of short acting beta agonists [ Time Frame: At baseline and follow-up after three months ] [ Designated as safety issue: No ]
- Levels of NT-proBNP and apelin [ Time Frame: At baseline and follow-up after three months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Sildenafil 50 mg three times daily
Other Name: Viagra
Placebo Comparator: 2
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730067
|Department of Pulmonary Diseases, Århus Sygehus|
|Århus, Denmark, Dk-8000|
|Department of Cardiology, Skejby sygehus|
|Århus N, Denmark, DK_8200|
|Principal Investigator:||Ole Hilberg, MDSC||Århus Sygehus|
|Principal Investigator:||Jens Erik Nielsen-Kudsk, MDSC||Skejby Sygehus|