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This study evaluates the drug Propranolol as an anti-adhesive therapy, compared with placebo, in patients with sickle cell disease. It enrolled patients aged 18 or older with electrophoresis-confirmed sickle cell disease. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Diagnosis by electrophoresis (HEP) of Hemoglobin (Hgb) SS or Hgb Sβ0 thalassemia (all patients followed at our clinic have HEP-confirmed diagnosis on file) * Age ≥ 18 years * Blood pressure (BP) Systolic ≥ 95mm Hg and Diastolic ≥ 50mm Hg * Heart rate (HR) ≥ 70 and ≤ 110 bpm * Oxygen saturation by pulse oximeter and at room air ≥ 92% * Hematocrit (Hct) ≥ 20% and Hb \> 6.0 g/dL * Euthyroid status as indicated by normal Thyroid Stimulating Hormone (TSH) * SS RBCs obtained during screening period demonstrating an adhesion response to epinephrine of 40% over non-stimulated baseline adhesion to endothelial cells * Capacity to understand and sign informed consent Exclusion Criteria: * History of vaso-occlusive episode during the 6 wks prior to screening * RBC transfusion during the 3 months prior to study entry * Ongoing pregnancy * History of heart failure, myocardial infarct (MI), bradyarrhythmias, conduction defects * History of asthma or reactive airway disease * History of thyroid disease * Diabetes * Renal insufficiency (BUN \>21 mg/dL and/or Creatinine \>1.4 mg/dL) * Use during the screening or study period of any of the following medications: antihypertensives, diuretics, thyroid replacement therapy, anti-arrhythmia medications, bronchodilators, inhaled steroids, insulin, or hypoglycemic medication * History of allergy to sulfonamides