Clinical trial NCT00730067: Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
Official title: Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COPD
Pulmonary Hypertension
Keywords: COPD
Pulmonary hypertension
Sildenafil
NT-pro BNP
apelin
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
* A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
* Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
* Age \> 18
* Informed written consent.
* Reliable anticonception for fertile women.

Exclusion Criteria:

* Rheumatic disease limiting walking capacity.
* Exacerbation in COPD during the study.
* Age\>80 years
* FEV1 \< 25 % of predicted.
* Allergy towards contents of sildenafil or placebo tablets.
* Fall in blood pressure of \> 30 mmHg systolic or \>20 mmHg diastolic after intake of the first dose of trial medication.
* Fall in peripheral saturation of \> 5% after intake of the first dose of trial medication.
* Treatment with nitrous vasodilators or aminophyllamines.

Primary outcomes:
measure: 6 minute walk test
timeFrame: at base line, after 2 hours and after 3 months
Secondary outcomes:
measure: assessment of life quality
timeFrame: At baseline and follow up after three months
measure: Systolic pulmonary pressure
timeFrame: At baseline and follow-up after three months
measure: Activity of symptoms measured by use of short acting beta agonists
timeFrame: At baseline and follow-up after three months
measure: Levels of NT-proBNP and apelin
timeFrame: At baseline and follow-up after three months
Other outcomes:
Locations:
city: Århus N
country: Denmark
facility: Department of Cardiology, Skejby sygehus
city: Århus
country: Denmark
facility: Department of Pulmonary Diseases, Århus Sygehus
Study officials:
affiliation: Århus Sygehus
name: Ole Hilberg, MDSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Skejby Sygehus
name: Jens Erik Nielsen-Kudsk, MDSC
role: PRINCIPAL_INVESTIGATOR
References: