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Published on: July 7, 2016
DAPA-HF applicability: the point of view of a cardiology setting
Massimo Iacoviello1, Marco Marini2, Mauro Gori3
1Medical and Surgical Sciences Department, University of Foggia, Foggia, Italy.
Insights
Sodium-glucose cotransporter 2 inhibitors (SGLT2-i) show promise for heart failure (HF) patients. A study found 73% of Italian heart failure with reduced ejection fraction patients met eligibility criteria for a key trial.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Sodium-glucose cotransporter 2 inhibitors (SGLT2-i) demonstrate efficacy in reducing heart failure (HF) hospitalizations, chronic kidney disease (CKD) progression, and mortality.
- Real-world data is crucial for understanding treatment generalizability beyond clinical trial populations.
Purpose of the Study:
- To evaluate the eligibility of patients with heart failure with reduced ejection fraction (HFrEF) in the Italian Network on Heart Failure (IN-HF) registry for the DAPA-HF trial criteria.
- To assess the applicability of SGLT2 inhibitor findings to contemporary HFrEF patient cohorts.
Main Methods:
- Analysis of 3415 HFrEF patients from the IN-HF registry.
- Comparison of patient characteristics against the DAPA-HF trial population (4744 patients).
- Assessment of theoretical eligibility for DAPA-HF inclusion criteria.
Main Results:
- 3415 IN-HF patients had overlapping baseline characteristics with DAPA-HF participants.
- A theoretical eligibility rate of 73% for DAPA-HF criteria was observed in the IN-HF cohort.
- The IN-HF population showed a lower prevalence of type 2 diabetes and ischemic heart failure etiology compared to DAPA-HF.
Conclusions:
- A significant majority of contemporary HFrEF patients followed in cardiology settings meet eligibility criteria for trials like DAPA-HF.
- Findings suggest that the benefits of SGLT2 inhibitors observed in clinical trials are likely generalizable to a broader HFrEF population.
- This study provides valuable insights for clinicians and policymakers regarding SGLT2 inhibitor use in real-world HFrEF management.
Abstract:
Randomised clinical trials, observational studies, and meta-analyses have shown that sodium-glucose cotransporter 2 inhibitors (SGLT2-i) reduce the risk of hospitalisation for heart failure (HF), chronic kidney disease (CKD) progression, and mortality in patients with HF, irrespective of the presence of type 2 diabetes mellitus. However, real-world epidemiology may differ from clinical trial populations, thereby limiting generalisability and delaying the introduction of novel treatments in clinical practice.The aim of the present study was to assess the prevalence of DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) inclusion criteria in a population of HF with reduced ejection fraction (HFrEF) patients enrolled in the Italian Network on Heart Failure (IN-HF) registry.Overall, 3415 IN-HF patients matched the 4744 patients in DAPA-HF, overlapping for most baseline characteristics (e.g. similar average ejection fraction), with a slightly lower prevalence of type 2 diabetes and of HF ischaemic aetiology and a higher percentage of NYHA class II patients. The theoretical eligibility to DAPA-HF in a cardiology setting resulted to be 73%.The availability of an easily accessible database from a large nationwide prospective registry allows to provide insights to clinicians and policy makers on the applicability of the DAPA HF findings to a contemporary population of HFrEF patients followed by cardiologists. It is reasonable to assume that the results of this analysis can be applicable to the entire SGLT2-ir class of drugs.
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