Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)

University of North Carolina (UNC)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Pulmonary Hypertension

Treatments

Drug: Tadalafil

Study type

Interventional

Funder types

Other

Industry

Identifiers

09-2326

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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