Duke Clinical Research Institute - Clinical Trial Results ：杜克临床研究所临床试验结果[精品].ppt

Red Cell Distribution Width (RDW) as a Novel Prognostic Marker in Heart Failure: Data from the CHARM Program and the Duke Databank Study Objective To identify prognostic biomarkers from a wide range of routine laboratory measures in symptomatic heart failure patients Derivation Dataset: CHARM Replication Dataset: Duke Databank Derivation Dataset CHARM North American Cohort N=2679 Enrollment March 1999 - March 2001 Median follow-up of 34 months Major enrollment criteria included: Symptomatic chronic HF 4 weeks duration Serum Cr 3 mg/dl, K 5.5 mmol/L Absence of MI or stroke in the prior 4 weeks Absence of non-cardiac disease judged to limit 2-year survival Methods Blood samples were collected at time of randomization n=1085 CHARM-Preserved (EF 40%) n=931 CHARM-Added (concurrent ACEI + EF ≤ 40%) n=663 CHARM-Alternative (ACEI intolerance + EF ≤ 40%) 36 measures: Chemistry: BMP, Ca/Mg/P, LFTs, lipids, CK, uric acid Hematology: CBC, differential, HbA1c CV death and HF hospitalizations were the 1o endpoint Cox proportional hazards modeling Clinical Variables by HF Hosp or CV Death Baseline Characteristics No event Event (N=1727) (N=952) History Age (year) 64.1 67.4 Etiology (ischemic) 65.0% 71.5% NYHA Class III 56.1% 70.1% NYHA Class IV 1.3% 5.5% Prior hospitalization for HF 62.4% 77.7% Ejection Fraction 0.40 0.35 Stroke 9.4% 12.7% Diabetes Mellitus 30.8% 48.8% Atrial fibrillation 25.3% 35.2% Physical Exam Systolic BP (mmHg) 129.1 126.5 Pulmonary crackles 10.5% 16.8% Cardiomegaly 8.4% 20.1% Key Laboratory Parameters by Outcome Mean SD Mean SD Sodium (mmol/l) 140.4 2.9 140.0 3.2 Urea nitrogen (mg/dl) 25 12 32 17 Creatinine (mg/dl) 1.1 0.4 1.3 0.9 Albumin (g/dl) 4.15 0.31 4.07 0.33 Bilirubin Total (mg/dl) 0.61 0.32 0.72 0.47 Uric Acid (mg/dl) 6.7 2.0 7.6 2.3 Cholesterol (mg/dl) 197 46 189 50 White cell count (103/mm3) 7.2 2.1 7.6 2.3 Lymphocytes (%) 26.5 8.4 23.6 8.7 Hemoglobin (g/dl) 13.7 1.5 13.4 3.1