Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension - Full Text View

Sponsors and Collaborators:	University of Cincinnati Actelion
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00581607

Purpose

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.

Condition	Intervention	Phase
Sarcoidosis Pulmonary Arterial Hypertension	Drug: Bosentan Drug: Placebo	Phase II Phase III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension Sarcoidosis

Drug Information available for: Bosentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Improvement in six minute walk distance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in pulmonary hemodynamics [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Improvement in quality of life with therapy [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Safety of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid
2: Placebo Comparator	Drug: Placebo Placebo twice a day

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581607

Contacts

Contact: Robert P Baughman, MD	513-584-5225	bob.baughman@uc.edu
Contact: Stacy Harman	513-584-2196	stacy.harman@uc.edu

Locations

United States, New York
Mount Sinai	Recruiting
New York, New York, United States
Contact: Maria Padilla maria.padilla@mssm.edu
Principal Investigator: Maria Padilla
Principal Investigator: Alvin Teirstein
United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD 513-584-5225 bob.baughman@uc.edu
Contact: Elyse E Lower 513-584-3829 ELower@ohcmail.com
Sub-Investigator: Peter Engel, MD
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States
Contact: Dan Culver CULVERD@ccf.org
Principal Investigator: Dan Culver

Sponsors and Collaborators

University of Cincinnati

Actelion

Investigators

Principal Investigator:

Robert P Baughman, MD

University of Cincinnati

More Information

Responsible Party:	University of Cincinnati ( Robert P. Baughman )
Study ID Numbers:	BOSAPAH-1, 7-3-22-1
Study First Received:	December 26, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00581607
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

Sarcoidosis

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Lymphatic Diseases
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Sarcoidosis
Lymphoproliferative Disorders
Bosentan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009