Rationale, design, and methods for a Coreg (Carvedilol) heart failure registry (COHERE)

Background: The success of beta-blocking agents in clinical trials of heart failure (HF) has led to a widespread call for their increased use, which a ssumes these agents will perform as well in the usual care setting. Given t he traditional contraindication of the use of beta-blocking agents in KF, a nd their perception as difficult to use in HF, observing how they perform i n 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. Methods: The Coreg (brand of carvedilol; Smitkline Beecham Pharmaceuticals, Philadelphia, PA) Heart Failure Registry (COHERE) is intended to collect d ata on outcomes and other clinical variables in a typical HF population and to observe experience with carvedilol in the hands of community practition ers. COHERE does not include any specific patient selection or exclusion cr iteria. The decision to use carvedilol is entirely at the discretion of the participant physician, based on evidence of HF as judged by assessments th e practitioner usually uses. All patients will be followed for 1 year, with information on outcomes and other clinical variables collected and analyze d 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 enrol l approximately 6.000 patients. Conclusions: COHERE will be the first and largest prospective observational experience with a new treatment, ie, carvedilol, in patients with HF manag ed in the usual care setting and should provide valuable information about this new treatment in this environment compared with the more rigid clinica l trials setting.