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Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01324999
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborators:
Eli Lilly and Company
United Therapeutics
University of Cincinnati
Information provided by (Responsible Party):
H. James Ford, MD, University of North Carolina, Chapel Hill

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Tadalafil Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Study Start Date : March 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sarcoid Associated Pulm. Hypertension
Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.
 Drug: Tadalafil
20mg/day for one month then 40mg/day for additional 4 months


Outcome Measures
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Primary Outcome Measures :
  1. 6 Minute Walk Distance [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]

Secondary Outcome Measures :
  1. Resting Oxygen Saturation [ Time Frame: Baseline, Week 24 ]
    Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.

  2. Oxygen Desaturation During 6 Minute Walk Test [ Time Frame: Baseline, Week 24 ]
    Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test

  3. Maximum Borg Dyspnea Score During 6 Minute Walk Test [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
    The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea.

  4. Brain Natriuretic Peptide Level [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
  5. Short Form-36 Global Score [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
    SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best).

  6. St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
    The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

  7. Number of Participants With Change in WHO Functional Class (WHO FC) [ Time Frame: Baseline, Week 24 ]
    The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324999


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eli Lilly and Company
United Therapeutics
University of Cincinnati
Investigators
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Principal Investigator: Hubert J Ford, M.D. University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: H. James Ford, MD, Assistant Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01324999    
Other Study ID Numbers: 09-2326
First Posted: March 29, 2011    Key Record Dates
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: June 2017
Keywords provided by H. James Ford, MD, University of North Carolina, Chapel Hill:
Sarcoidosis Associated Pulmonary Hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Lung Diseases
Sarcoidosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
 Lymphatic Diseases
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents