Acute Heart Failure: Perspectives from a Randomized Trial and a Simultaneous Registry
Background—Randomized controlled trials (RCT) are limited by their generalizability to the broader non-trial population. In order to provide a context for the Acute Study of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial, we designed a complementary registry to characterize clinical characteristics, practice patterns, and in-hospital outcomes of acute heart failure (AHF) patients.
Methods and Results—Eligible patients for the registry included those with a principal diagnosis of AHF (ICD-9-CM 402 and 428; ICD-10 I50.x, I11.0, I13.0, I13.2) from 8 sites participating in ASCEND-HF (n=697 patients, 2007 to 2010). Baseline characteristics, treatments and hospital outcomes from the registy were compared to ASCEND-HF RCT patients from 31 Canadian sites (n=465, 2007 to 2010). Patients in the registry were older, more likely to be female and have chronic respiratory disease, less likely to have diabetes: they had a similar incidence of ischemic HF, atrial fibrillation and similar BNP levels. Registry patients had higher systolic blood pressure (Registry: median 132 mmHg [interquartile range 115-151 mmHg]; RCT: median 120 mmHg [interquartile range 110-135 mmHg]) and ejection fraction (Registry: median 40% [interquartile range 27-58%]; RCT: median 29% [interquartile range 20-40 mmHg]) than RCT patients. Registry patients presented more often via ambulance and had a similar total length of stay as RCT patients. In-hospital mortality was significantly higher in the registry compared to the RCT patients (9.3% vs. 1.3%, p<0.001) and this remained after multivariable adjustment (odds ratio 6.6, 95% CI 2.6-16.8, p<0.001).
Conclusions—Patients enrolled in a large RCT of AHF differed significantly based on clinical characteristics, treatments and inpatient outcomes from contemporaneous patients participating in a registry. These results highlight the need for context of RCTs to evaluate generalizability of results and especially the need to improve clinical outcomes in AHF.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.
- Received May 1, 2012.
- Accepted August 31, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited