Speakers
Adam DeVore, MD, MHS
Associate Professor of Medicine
Duke University Medical Center
Duke Clinical Research Institute
Lars Lund, MD, PhD
Professor of Cardiology
Karolinska Institutet
Karolinska University Hospital
Topic
SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-based Randomized Clinical Trial
Keywords
Heart Failure; SPIRRIT-HFpEF; Randomized clinical trial; Spironolactone; Eplerenone; Swedish Heart Failure Registry (SwedeHF)
Key Points
- The SPIRRIT-HFpEF trial, conducted Sweden and the US, was a randomized pragmatic clinical trial of spironolactone or eplerenone in heart failure.
- Death from heart disease is decreasing while death from Heart Failure is increasing.
- The SPIRRIT-HFpEF trial focused on improving the trajectory for the growing heart failure population.
- Patients treated with Spironolactone had a modest but not statistically significant improvement over placebo, but total hospitalizations were less.
- Patients with a lower ejection fraction were more likely to benefit than patients with a higher ejection fraction.
- The Swedish Heart Failure Registry (SwedeHF) has been collecting data from HF patients since 2000.’
Discussion Themes
The hardest aspect of a clinical trial is recruitment and enrollment. Patients are spread out over the health care system. The challenge is getting staff and personnel to do the work of screening and prescreening.
In the SPIRRIT-HFpEF, the drawbacks of not blinding were small and the costs of blinding would have been huge.
Learn more about the SPIRRIT-HFpEF trial and the Swedish Heart Failure Registry. Read about the SPIRRIT-HFpEF trial results.
Tags
#pctGR, @Collaboratory1