Masoudi Frederick A, Havranek Edward P, Wolfe Pam, Gross Cary P, Rathore Saif S, Steiner John F, Ordin Diana L, Krumholz Harlan M
Division of Cardiology, Denver Health Medical Center, Denver, Colo 80204, USA.
Am Heart J. 2003 Aug;146(2):250-7. doi: 10.1016/S0002-8703(03)00189-3.
Although it is widely accepted that clinical trials in heart failure may not apply to older populations, the magnitude of the discrepancy between trial populations and patients seen in community-based practice are not known. Our objective was to determine the proportion of older persons meeting enrollment criteria of randomized controlled trials of agents that prolong life in heart failure.
We conducted a cross-sectional study of Medicare beneficiaries >64 years old with the principal diagnosis of heart failure who were discharged from acute care hospitals in the United States between April 1998 and March 1999. Enrollment criteria of the Studies of Left Ventricular Dysfunction (SOLVD), Metroprolol CR/LX Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF), and Randomized Aldactone Evaluation Study (RALES) trials were applied to the population, and the proportions meeting the criteria were determined by subgroups of age and sex.
Of the 20,388 patients studied, 18%, 13%, and 25% met the enrollment criteria of the SOLVD, MERIT-HF, and RALES trials, respectively. Although trial eligibility was less than a third for any sex or age group, significantly fewer women than men met trial criteria (13% vs 23% for SOLVD, 11% vs 17% for MERIT-HF, and 21% vs 32% for RALES, P <.0001 for all). The oldest patients were also less likely to fulfill enrollment criteria. The proportion of all patients not included because of preserved left ventricular systolic function was twice as large as the proportion meeting the inclusion criteria for any trial.
A minority of hospitalized older persons with heart failure fit the profile of populations of clinical trials. There is an urgent need for research in heart failure for typical heart failure patients, including the very old, women, and patients with preserved left ventricular systolic function.
尽管人们普遍认为心力衰竭的临床试验可能不适用于老年人群，但试验人群与社区实践中所见患者之间差异的程度尚不清楚。我们的目的是确定符合延长心力衰竭患者生命药物随机对照试验入组标准的老年人比例。
我们对1998年4月至1999年3月期间在美国急性护理医院出院的64岁以上主要诊断为心力衰竭的医疗保险受益人进行了一项横断面研究。将左心室功能障碍研究（SOLVD）、美托洛尔控释/长效制剂治疗充血性心力衰竭随机干预试验（MERIT-HF）和随机螺内酯评估研究（RALES）试验的入组标准应用于该人群，并按年龄和性别亚组确定符合标准的比例。
在研究的20388例患者中，分别有18%、13%和25%符合SOLVD、MERIT-HF和RALES试验的入组标准。尽管任何性别或年龄组的试验合格性均不到三分之一，但符合试验标准的女性明显少于男性（SOLVD分别为13%对23%，MERIT-HF为11%对17%，RALES为21%对32%，所有P<0.0001）。年龄最大的患者也不太可能符合入组标准。因左心室收缩功能保留而未纳入的所有患者比例是符合任何试验纳入标准患者比例的两倍。
少数住院的老年心力衰竭患者符合临床试验人群的特征。迫切需要针对典型心力衰竭患者开展心力衰竭研究，包括高龄患者、女性和左心室收缩功能保留的患者。
