Pulmonary Hypertension and Imatinib
Completed
Conditions studied: PAH
In brief
The purpose of the study is to determine whether circulating molecular and cellular biomarkers are predictive of imatinib effect on pulmonary artery hypertension.
Key facts
- Study ID
- NCT01092897
- Run by
- The Cleveland Clinic
- People needed
- 130
- Starts
- 2010-03-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- from Imatinib Trial
- Male or Female 18 years or older
- A current diagnosis or Pulmonary Arterial Hypertension according to the Dana Point 2008 Meeting: WHO Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect (ASD, VSD, or PDA), or PAH associated with diet therapies or other drugs
- A PVR>1000dynes.sec.cm-5(as assess by RHC at screening or in the 2 months preceding the screening visit despite treatment with two or more specific PAH therapies, including endothelin receptor antagonists (ERA), phosphodiesterase 5 inhibitors (PDE5), or inhaled, intravenous or oral prostacyclin analogues for ≥3 months. On stable background therapy doses for ≥ 30 days except for warfarin (≥30 days but doses can vary even within the mouth before enrollment)
- WHO Functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies must be an inhaled, intravenous or oral prostacyclin analogue, unless the subject has been shown to be intolerant of prostacyclin analogues.
- 6MWD≥150meters and ≥450meters at screening. Distances of two consecutive 6MWTs should be within 15% of one another.
- Ability to provide written informed consent
- Exclusion Criteria: from Imatinib Trial
- Women of childbearing potential who are not practicing birth control methods.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of positive hCG laboratory test (> 5 mIU/MI)
- Have previously received treatment with imatinib
- In treatment with chronic nitric oxide therapy
- Pre-existing lung disease including parasitic diseases affecting lungs, congenital abnormalities of the lungs, thorax or diaphragm or bronchial asthma associated with chronic hypoxia that may contribute to severity of PAH
- With a pulmonary capillary wedge pressure >15 mm Hg to rule out PAH secondary to left ventricular dysfunction
- With a diagnosis of pulmonary artery or vein stenosis
- With other diagnosis of PAH in WHO Diagnostic Group 1 re excluded including congenital systemic to pulmonary shunts (large, small that not surgically repaired, portal hypertension, HIV infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopthaies, myeloproliferative disorders)
- With a diagnosis of PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis, histiocytosis X, lympangiomatosis, compression of pulmonary vessels).
- With deficient thrombocyte function, thrombocytopenia >50x109/L(50x103/µL)
- With a history of acute heart failure or chronic left sided heart failure
- With uncontrolled systemic arterial hypertension, systolic >160mmHg or diastolic >90mmHg
- With hemoglobin <100g/L (10 g/dl)
- With deficiencies of blood coagulation, inherited or acquired blood disorders, factor XII, factor XIII; decreased generation of coagulation factors due to acute or chronic liver diseases, efficient coagulation due to auto-antibodies against coagulation factors such as in lupus anticoagulant
- With disseminated intravascular coagulation (DIC)
- With evidence of major bleeding or intracranial hemorrhage
- With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa
Where it is running
- University of Colorado Denver — Aurora, Colorado, United States
- Cleveland Clinic Florida — Weston, Florida, United States
- Johns Hopkins — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- UT Southwestern Medical Center of Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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