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OpenTrials
Completed

NCT Number: NCT01324999

Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

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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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tadalafil

Drug

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

Primary outcomes

  1. 6 Minute Walk Distance

    Time frame: Baseline, Week 8, Week 16, Week 24

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eli Lilly and Company
  • United Therapeutics
  • University of Cincinnati

Registry information

Acronym: SAPH

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2011
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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