Chronic thromboembolic pulmonary hypertension: CTEPH
Conditions
Interventions
Right ventricle biopsy performed during pulmonary endarterectomy
Sponsors
Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Males or females 20 years old or more and less than 80 years of age 2. Willing and able to complete informed consent form. 3. Documented diagnosis of CTEPH: o Mean pulmonary arterial pressure >25 mm Hg, pulmonary capillary wedge pressure =/< 15 mm Hg and pulmonary vascular resistance >240 dynes/sec/cm5 (measured by catheter). o Segmental perfusion defects with normal ventilation (measured by ventilation/perfusion scan); stable for at least 6 months after receiving stable doses of anticoagulants. o Pulmonary arterial stenosis and/or obstruction (measured by pulmonary angiography and CT angiography). 4. CTEPH patients who are scheduled to undergo pulmonary endarterectomy.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Clinically significant biochemical abnormality. 2. Clinical evidence of pre-existing neuropathy. 3. Use of investigational product or device within 30 days prior to dosing, or known requirement for any investigational agent prior to completion of all scheduled study assessments. 4. Known to be positive for human immunodeficiency virus (HIV). 5. Additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities, including past history of myocardial infarction, unstable angina, and poorly controlled diabetes mellitus. 6. Blood results (performed within 14 days from study registration) as outlined below: o Creatinine > 2.0 mg/dl o BUN > 30 mg/dl o ALT >150 U o AST >150 U 7. Pregnant or lactating at screening, or planning to become pregnant (self or partner) at any time during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of mitochondrial dysfunction in right ventricle myocardial cells by using biopsy samples extracted during pulmonary endarterectomy | — |
Countries
Japan
Contacts
Public ContactSeiichiro Sakao
Graduate School of Medicine, Chiba University Department of Respirology (B2)
Outcome results
None listed