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Rosiglitazone to Treat Patients With Heart Failure and Glucose Intolerance or Type II Diabetes
Bu çalışma, kalp yetmezliği (heart failure) ile birlikte glukoz intoleransı veya Tip II diyabeti olan hastalarda Rosiglitazon (Avandia) ilacını inceliyor. Belirli kalp fonksiyonu ve insülin direnci kriterlerini karşılayan 21 yaş üstü hastalar ve yaş uyumlu sağlıklı gönüllüler dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
* INCLUSION CRITERIA: Adult normal volunteers, age matched (55-75 years of age) Adult patients greater than 21 years of age who meet the following criteria: * Heart Failure due to ischemic heart disease or of idiopathic etiology * Depressed LV systolic function, EF less than or equal to 0.45 by Radionuclide Angiography (MUGA) * New York Heart Association Functional Class II or III * Patient stable on current heart failure therapy * Evidence of insulin resistance or type II diabetes on insulin-sensitivity screening * No predicted cardiac revascularization therapy requirements EXCLUSION CRITERIA: Pregnant or lactating History of admission for acute heart failure exacerbation within last one month Acute myocardial infarction within the last three months Cardiac resynchronization pacemaker placement within the last three months Genetic defect known to have induced heart failure Serum creatinine greater than 2.5 mg/dL. Liver transaminase levels greater than 2.5 x upper limit of normal Requirement for insulin therapy to control blood glucose Current use of thiazolidinedione for diabetic control or history of discontinuation of thiazolidinedione therapy following development of side effects Uncontrolled blood glucose levels or the use of insulin therapy to control diabetes Immune compromise including chronic HIV, HBV, and HCV infection Chronic systemic inflammatory disease such as SLE, rheumatoid arthritis, collagen vascular disease Participation in unrelated research involving investigational pharmacological agent 30 days before planned dosing Current alcohol or drug abuse Inability to provide informed consent