Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00730067|
Recruitment Status : Withdrawn (As a single center, it was not possible to recruit enough patients with pulmonary hypertension)
First Posted : August 8, 2008
Last Update Posted : August 23, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD Pulmonary Hypertension||Drug: sildenafil Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Sildenafil 50 mg three times daily
Other Name: Viagra
Placebo Comparator: 2
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.
- 6 minute walk test [ Time Frame: at base line, after 2 hours and after 3 months ]
- assessment of life quality [ Time Frame: At baseline and follow up after three months ]
- Systolic pulmonary pressure [ Time Frame: At baseline and follow-up after three months ]
- Activity of symptoms measured by use of short acting beta agonists [ Time Frame: At baseline and follow-up after three months ]
- Levels of NT-proBNP and apelin [ Time Frame: At baseline and follow-up after three months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730067
|Department of Cardiology, Skejby sygehus|
|Århus N, Denmark, DK_8200|
|Department of Pulmonary Diseases, Århus Sygehus|
|Århus, Denmark, Dk-8000|
|Principal Investigator:||Ole Hilberg, MDSC||Århus Sygehus|
|Principal Investigator:||Jens Erik Nielsen-Kudsk, MDSC||Skejby Sygehus|