Early Therapy of Pulmonary Arterial Hypertension

NCT00909337 | Completed

• 1 other identifier: 18-295 ex 06/07
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise-induced increase of the pulmonary arterial pressure may be an early sign of pulmonary arterial hypertension. It has been shown that patients with normal pulmonary arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a decreased exercise-capacity and may have a worse prognosis compared to patients with normal pulmonary arterial pressure values at rest and during exercise. According to the currently used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with a risk for pulmonary arterial hypertension (connective tissue disease) and increased pulmonary arterial pressure values during exercise are receiving a therapy with a dual endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial hypertension. The therapy effect is than compared to the recorded changes before the introduction of this therapy.

Conditions

Pulmonary Hypertension; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change of mean pulmonary arterial pressure at 50W under therapy with Bosentan compared to change of mean pulmonary arterial pressure at 50W before the introduction of therapy with Bosentan

  12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy

Secondary Outcomes (1)

• pulmonary vascular resistance, peak oxygen uptake

  12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy

Study Arms (1)

Bosentan

OTHER

In this study, all participants have normal pulmonary arterial pressure at rest and elevated pulmonary arterial pressure during exercise. First, they were followed up for a year and were controlled after 1 year without specific therapy for pulmonary hypertension. Then Bosentan was introduced. A second control showing the effects of the therapy was done after 6 months. The changes in the "therapy period" can be compared with the changes in the "follow up period".

Drug: Bosentan

Interventions

Bosentan DRUG

2x62.5mg for 4 weeks, then 2x125mg

Also known as: Tracleer

Bosentan

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• exercise-induced pulmonary hypertension
• systemic sclerosis

You may not qualify if:

• relevant pulmonary obstruction or restriction
• relevant left cardiac disease
• recent changes in medical therapy
• recent major operations
• recent major cardiovascular diseases
• inability to perform exercise

Sponsors & Collaborators

• Medical University of Graz: lead
• Actelion: collaborator

Study Sites (1)

Medical University of Graz, Pulmonology

Graz, 8036, Austria

Location

Related Publications (1)

• Kovacs G, Maier R, Aberer E, Brodmann M, Graninger W, Kqiku X, Scheidl S, Troster N, Hesse C, Rubin L, Olschewski H. Pulmonary arterial hypertension therapy may be safe and effective in patients with systemic sclerosis and borderline pulmonary artery pressure. Arthritis Rheum. 2012 Apr;64(4):1257-62. doi: 10.1002/art.33460. Epub 2011 Nov 11.

  PMID: 22127844 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Scleroderma, Systemic

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

AU (1)