Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-10-31

Brief Summary

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This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.

Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

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Detailed Description

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Conditions

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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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Sarcoid Associated Pulm. Hypertension

Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

20mg/day for one month then 40mg/day for additional 4 months

Interventions

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Tadalafil

20mg/day for one month then 40mg/day for additional 4 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven sarcoidosis
* Mean pulmonary artery pressure \> 25 mmHg at rest or 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% predicted
* Forced expiratory volume in 1 second (FEV1) \> 40% predicted
* 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, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) 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
* Severe systemic hypotension \< 90/50
* History of priapism
* Patients with congestive heart failure (left ventricular dysfunction) LVEF \< 45% by echocardiogram
* 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, chronic thromboemboli)
* Use within 1 month of an sildenafil or vardenafil
* WHO functional class IV status
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study
* Subjects with liver function abnormalities (ALT or AST \> 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
* Advanced kidney failure (GFR \< 30 ml/min at screening or at baseline)
* History of hypersensitivity reaction or adverse effect related to tadalafil
* Pregnant or lactating women
* Concomitant use of nitrates (any form) either regularly or intermittently
* Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole)
* Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No