Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— BOSAPAH  

Official title:

Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581607
• Other study ID #: BOSAPAH-1
• Secondary ID: 7-3-22-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: April 10, 2013
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.

Description:

Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with known sarcoidosis 21.

• Age 18 or greater

• Patients with documented pulmonary hypertension with a PA mean > 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg.

• Patients with WHO class II or III

• Six minute walk distance of between 100 to 500 meters

• Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab

• Patients able to provide written consent

Exclusion Criteria:

• Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.

• Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%

• Patients with World Health Organization (WHO) class IV status.

• Patients who are pregnant or breast feeding

• Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%

• Cardiac index < 2.0 liters and/or right atrial pressure >15 mm Hg

• Significant liver dysfunction not due to sarcoidosis.

• Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.

• Patients unable to perform the 6 minute walk study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Sarcoidosis

Intervention

Drug:
• Bosentan
62.5 mg bid for 4 weeks, then 125 mg bid
• Placebo
Placebo twice a day
• Bosentan
drug given for 16 weeks
• Placebo
placebo

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Mount Sinai	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in six minute walk distance		16 weeks	No
Secondary	Change in pulmonary hemodynamics		16 weeks	No
Secondary	Improvement in quality of life with therapy		48 weeks	Yes
Secondary	Safety of treatment		48 weeks	Yes