Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

Phase 4

Withdrawn

• Conditions: COPD; Pulmonary Hypertension
• Interventions: Drug: sildenafil; Drug: placebo

• Registration Number: NCT00730067
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Study Start: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sildenafil	Sildenafil treatment
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
6 minute walk test	at base line, after 2 hours and after 3 months

Secondary Outcome Measures

Name	Time	Method
assessment of life quality	At baseline and follow up after three months
Systolic pulmonary pressure	At baseline and follow-up after three months
Activity of symptoms measured by use of short acting beta agonists	At baseline and follow-up after three months
Levels of NT-proBNP and apelin	At baseline and follow-up after three months

Trial Locations

Locations (2)

Department of Cardiology, Skejby sygehus; 🇩🇰 Århus N, Denmark

Department of Pulmonary Diseases, Århus Sygehus; 🇩🇰 Århus, Denmark