ArticleEuropean heart journal. Quality of care & clinical outcomes2022
Generalizability of randomized controlled trials in heart failure with reduced ejection fraction.
Article in European heart journal. Quality of care & clinical outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Sex differences in pharmacological treatment of heart failure: a meta-analysis of randomized trials.European heart journal · 2026Pooled it
- Ten years real-world experience with sacubitril/valsartan in patients with heart failure with reduced ejection fraction.ESC heart failure · 2026Pooled it
- Effect of pulmonary artery pressure-guided management on outcomes of patients with heart failure outside clinical trials: A systematic review and meta-analysis of real-world evidence with the CardioMEMS Heart Failure System.European journal of heart failure · 2025Pooled it
- Clinical Impact of Digital Health Interventions with Educational Components for Patients with Heart Failure: A Systematic Review and Meta-Analysis.Healthcare (Basel, Switzerland) · 2026Review
- A novel digital twin strategy to examine the implications of randomized clinical trials for real-world populations.NPJ digital medicine · 2026Article
- Demographics and clinical outcomes of patients with acute heart failure : The Acute Heart Failure Registry from the Clinic Ottakring (AHF-COR Registry).Wiener klinische Wochenschrift · 2026Article
- Evaluating the sampling effect of propensity score matching for reducing selection bias in medical data.Frontiers in public health · 2026Article
- Effectiveness of Sacubitril/Valsartan in Reducing Hospitalizations in Older Belgian Adults with Heart Failure and Reduced Ejection Fraction: An Age-Stratified Study.Drugs & aging · 2026Article
- Applicability of guideline-informing lipid-lowering clinical trials to contemporary real-world patients with atherosclerotic cardiovascular disease.European heart journal. Quality of care & clinical outcomes · 2025Article
- "Two-stage resection of synchronous liver metastases in colorectal cancer leads to a survival benefit: a retrospective comparative cohort study".Langenbeck's archives of surgery · 2025Article
- Changes in Cardiovascular Risk Factors and Health Care Expenditures Among Patients Prescribed Semaglutide.JAMA network open · 2025Article
- Computational Phenomapping of Randomized Clinical Trial Participants to Enable Assessment of Their Real-World Representativeness and Personalized Inference.Circulation. Cardiovascular quality and outcomes · 2025Article
- Heart failure in Europe: Guideline-directed medical therapy use and decision making in chronic and acute, pre-existing and de novo, heart failure with reduced, mildly reduced, and preserved ejection fraction - the ESC EORP Heart Failure III Registry.European journal of heart failure · 2024Article
- Real-life effectiveness of sacubitril/valsartan in older Belgians with heart failure, reduced ejection fraction and most severe symptoms.Scientific reports · 2024Article
- Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE-HF.ESC heart failure · 2024Article
- Eligibility for omecamtiv mecarbil in a real-world heart failure population: Data from the Swedish Heart Failure Registry.PloS one · 2024Article
- RCT-Twin-GAN Generates Digital Twins of Randomized Control Trials Adapted to Real-world Patients to Enhance their Inference and Application.medRxiv : the preprint server for health sciences · 2023Article
- Article
- Guideline-directed medical therapy for HFrEF: sequencing strategies and barriers for life-saving drug therapy.Heart failure reviews · 2023Review
- Article
Corrections and comments
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Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHeart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejection fraction (HFrEF) in trials and observational registries. METHODS AND
resultsIndividual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients.
conclusionIn 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.
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