Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-11-30

Brief Summary

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

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Detailed Description

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Primary Endpoint: Change in 6 minute walk distance.

Conditions

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Sarcoidosis Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sarcoidosis associated pulmonary hypertension

Group Type EXPERIMENTAL

Ambrisentan

Intervention Type DRUG

ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months

Interventions

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Ambrisentan

ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months

Intervention Type DRUG

Other Intervention Names

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Letairis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No