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

This study has been withdrawn prior to enrollment.
(As a single center, it was not possible to recruit enough patients with pulmonary hypertension)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730067
First Posted: August 8, 2008
Last Update Posted: August 23, 2012
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.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Charlotte Andersen, University of Aarhus
  Purpose

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 Intervention Phase
COPD Pulmonary Hypertension Drug: sildenafil Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.

Resource links provided by NLM:


Further study details as provided by Charlotte Andersen, University of Aarhus:

Primary Outcome Measures:
  • 6 minute walk test [ Time Frame: at base line, after 2 hours and after 3 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
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)
Arms Assigned Interventions
Experimental: 1
Sildenafil treatment
Drug: sildenafil
Sildenafil 50 mg three times daily
Other Name: Viagra
Placebo Comparator: 2
placebo
Drug: placebo
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
Department of Cardiology, Skejby sygehus
Århus N, Denmark, DK_8200
Department of Pulmonary Diseases, Århus Sygehus
Århus, Denmark, Dk-8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Ole Hilberg, MDSC Århus Sygehus
Principal Investigator: Jens Erik Nielsen-Kudsk, MDSC Skejby Sygehus
  More Information

Responsible Party: Charlotte Andersen, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT00730067     History of Changes
Other Study ID Numbers: 2008-002237-73
First Submitted: August 4, 2008
First Posted: August 8, 2008
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Charlotte Andersen, University of Aarhus:
COPD
Pulmonary hypertension
Sildenafil
NT-pro BNP
apelin

Additional relevant MeSH terms:
Hypertension
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents