Generalisability of Randomised Controlled Trials in Heart Failure with Reduced Ejection Fraction.
Yvonne Mei Fong LimMegan MolnarIlonca VaartjesGianluigi SavareseMarinus J C EijkemansAlicia UijlEleni VradiKiliana Suzart-WoischnikJasper J BrugtsHans-Peter Brunner-La RoccaVanessa Blanc-GuillemaudFabrice CouvelardClaire BaudierTomasz DyszynskiSandra WaechterLars H LundArno W HoesBenoit TylFolkert W. AsselbergsChristoph GerlingerDiederick E GrobbeeMaureen CroninStefan KoudstaalPublished in: European heart journal. Quality of care & clinical outcomes (2021)
In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries.
Keyphrases
- heart failure
- acute heart failure
- end stage renal disease
- study protocol
- clinical trial
- phase iii
- newly diagnosed
- ejection fraction
- chronic kidney disease
- phase ii
- peritoneal dialysis
- randomized controlled trial
- cardiovascular events
- left ventricular
- type diabetes
- risk factors
- health insurance
- patient reported outcomes
- cardiac resynchronization therapy
- free survival