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Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoidosis; Pulmonary Hypertension

Intervention: Ambrisentan (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Medical University of South Carolina

Overall contact:
Marc A Judson, MD, Phone: 843-697-7272, Email: judsonma@musc.edu

Summary

Hypothesis: Ambrisentan (Letairis ) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Clinical Details

Official title: Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in 6 minute walk distance.

Detailed description: Primary Endpoint: Change in 6 minute walk distance. Secondary Endpoints:

- Safety

- Oxygen saturation at rest and with exercise

- Hospitalization

- Mortality

- WHO functional class

- Quality of life as measured by

- Short-form 36

- Sarcoidosis Health Questionnaire

- Dyspnea as measured by

- Borg Dyspnea Index

- St. George Respiratory Questionnaire

- Sarcoidosis activity as measured by the

- STAI sarcoidosis instrument (33)

- Prednisone dose

- Pulmonary function

- Forced vital capacity (FVC)

- Diffusion (DLCO)

- Endothelin-1 levels

- Bronchoalveolar lavage

- Plasma

- B-type natruetic peptide

- Inflammatory and fibrotic mediators (IL-2, IL-6, IL-12, IL-18, IL-23, TNF-α) in BALF

- Compliance with treatment

- Time to clinical worsening (defined by the initiation of ambrisentan treatment to the

first occurrence of death, lung transplantation, hospitalization for pulmonary arterial hypertension, arterial septostomy, a change in chronic prostanoid or sildenafil treatment due to protocol defined worsening criteria or study withdrawal due to additional of other clinically approved PAH therapeutic agents)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Biopsy proven sarcoidosis

- Mean pulmonary artery pressure > 25 mmHg at rest and greater than 30 mmHg with

exercise by right heart catheterization within 1 year prior to entry into study

- Pulmonary capillary wedge pressure ≤ 15 mmHg

- PVR values >3. 0 Woods units

- Forced vital capacity (FVC) >40%

- WHO functional class II or III

- Stable sarcoidosis treatment regimen for three months prior to entry into study

- 6 minute walk distance between 150-450 meters

- Stable dose of antihypertensive medications

- On no other medication to treat PAH (sildenafil, tadalafil, vardenafil, treprostinil,

epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study

- Non-pregnant females

Exclusion Criteria:

- Exercise limitation related to a non-cardiopulmonary reason (e. g. arthritis)

- Severe systemic hypertension > 170/95

- Patients with congestive heart failure (left ventricular dysfunction) or primary

right ventricular dysfunction

- Anticipation by the investigator for escalation in sarcoidosis treatment during the

course of the study

- Pulmonary hypertension related to etiology other than sarcoidosis (i. e. HIV,

scleroderma, etc.)

- Use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).

- WHO functional class IV status

- Patients with significant left ventricular dysfunction

- 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.

Locations and Contacts

Marc A Judson, MD, Phone: 843-697-7272, Email: judsonma@musc.edu

Northwestern University Medical Center, Chicago, Illinois, United States; Not yet recruiting
Peter Sporn, MD, Email: p-sporn@northwestern.edu

University of North Carolina Medical Center, Chapel Hill, North Carolina, United States; Not yet recruiting
James Ford, MD, Email: hford@unch.unc.edu

Medical Univerrsity of South Carolina, Charleston, South Carolina 29466, United States; Recruiting
Marc A Judson, MD, Email: judsonma@musc.edu

Additional Information

Starting date: November 2008
Last updated: February 25, 2009

Page last updated: August 23, 2015

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