Franciosa J A, Abraham W T, Fowler M, Gilbert E M, Greenberg B, Massie B M, Chen T, Lukas M A, Nelson J J
Mount Sinai School of Medicine and Cornell University, Weill Medical College, New York, New York, USA.
J Card Fail. 2000 Sep;6(3):264-71. doi: 10.1054/jcaf.2000.9675.
The success of beta-blocking agents in clinical trials of heart failure (HF) has led to a widespread call for their increased use, which assumes these agents will perform as well in the usual care setting. Given the traditional contraindication of the use of beta-blocking agents in HF, and their perception as difficult to use in HF, observing how they perform in the usual care setting could be critical in accelerating their widespread application. Carvedilol is the only beta-blocking agent currently approved in the United States for use in HF.
The Coreg (brand of carvedilol; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) Heart Failure Registry (COHERE) is intended to collect data on outcomes and other clinical variables in a typical HF population and to observe experience with carvedilol in the hands of community practitioners. COHERE does not include any specific patient selection or exclusion criteria. The decision to use carvedilol is entirely at the discretion of the participant physician, based on evidence of HF as judged by assessments the practitioner usually uses. All patients will be followed for 1 year, with information on outcomes and other clinical variables collected and analyzed at baseline, the end of titration, and at 6 and 12 months after reaching the maximum tolerated dose. About 600 participant physicians selected to be as representative as possible of the community practice setting will enroll approximately 6,000 patients.
COHERE will be the first and largest prospective observational experience with a new treatment, ie, carvedilol, in patients with HF managed in the usual care setting and should provide valuable information about this new treatment in this environment compared with the more rigid clinical trials setting.
β受体阻滞剂在心力衰竭（HF）临床试验中的成功促使人们广泛呼吁增加其使用，这一呼吁假定这些药物在常规治疗环境中也能有同样良好的表现。鉴于传统上β受体阻滞剂在HF治疗中的禁忌证，以及人们认为其在HF治疗中使用困难，观察它们在常规治疗环境中的表现对于加速其广泛应用可能至关重要。卡维地洛是目前美国唯一被批准用于HF治疗的β受体阻滞剂。
卡维地洛（Coreg，史密斯·克莱因·比彻姆制药公司生产，宾夕法尼亚州费城）心力衰竭注册研究（COHERE）旨在收集典型HF患者群体的预后及其他临床变量数据，并观察社区医生使用卡维地洛的经验。COHERE不包括任何特定的患者入选或排除标准。是否使用卡维地洛完全由参与研究的医生自行决定，依据的是医生通常采用的评估方法所判断的HF证据。所有患者将被随访1年，在基线、滴定结束时以及达到最大耐受剂量后的6个月和12个月收集并分析预后及其他临床变量信息。约600名经挑选以尽可能代表社区医疗环境的参与医生将招募约6000名患者。
COHERE将是在常规治疗环境下对HF患者使用新治疗方法（即卡维地洛）的首个也是最大规模的前瞻性观察性研究，与更为严格的临床试验环境相比，应能提供有关这种新治疗方法在该环境下的有价值信息。
