Acute heart failure: perspectives from a randomized trial and a simultaneous registry

Area of Science:

• Cardiology
• Clinical Research
• Public Health

Background:

• Randomized controlled trials (RCTs) often have limited generalizability to real-world patient populations.
• Acute heart failure (AHF) management requires understanding patient characteristics beyond trial participants.
• The Acute Study of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial provides a benchmark for AHF research.

Purpose of the Study:

• To characterize clinical features, treatment patterns, and in-hospital outcomes of AHF patients in a complementary registry.
• To compare registry patients with those enrolled in the ASCEND-HF RCT.
• To provide context for ASCEND-HF trial generalizability.

Main Methods:

• A registry of 697 AHF patients was conducted across 8 sites participating in ASCEND-HF (2007-2010).
• Registry data on baseline characteristics, treatments, and outcomes were compared with 465 ASCEND-HF RCT patients from 31 Canadian sites.
• Statistical analysis included multivariable adjustment for outcome comparisons.

Main Results:

• Registry patients were older, more likely female, had more chronic respiratory disease, and less diabetes mellitus than RCT patients.
• Registry patients had higher systolic blood pressure and ejection fraction but similar ischemic heart failure incidence and B-type natriuretic peptide levels.
• In-hospital mortality was significantly higher in the registry (9.3%) compared to the RCT (1.3%), with an adjusted odds ratio of 6.6.

Conclusions:

• Significant differences exist between AHF patients in a registry and those in a large RCT.
• These findings underscore the importance of contextualizing RCT results with real-world data.
• Improving clinical outcomes in AHF necessitates addressing the generalizability gap highlighted by comparing trial and registry populations.