Therapeutic implementation in patients with newly diagnosed heart failure: data from the italian multicenter registry OpTIMa-HF

Abstract Background/Introduction Patients with newly diagnosed (de novo) heart failure (HF) represent a continually growing clinical entity from an epidemiological point of view and there is still limited scientific evidence regarding the initial therapeutic approach and sequencing of disease-modifying drugs in this population. Purpose The aim of the Optimization of Therapy in the Italian Management of Heart Failure de novo (OpTIMa-HF de novo) Registry was to collect data on patients with newly diagnosed HF, with a specific focus on prescription patterns of European guideline-recommended therapies. Methods OpTIMa-HF de novo is an observational, multicenter registry conducted in hospital outpatient clinics and community-based ambulatory services. In the present analysis, patients with newly diagnosed HF were enrolled, regardless of the phenotype, and characterized based on demographic, clinical, laboratory, and instrumental data, with a specific focus on pharmacological therapies prescribed at the time of diagnosis and in early follow-up visits. Results 14 centers across Italy enrolled 453 patients with newly diagnosed HF median age 73.5 years; 64.5% male; median ejection fraction (EF) 43%, of which 225 (49.7%) had HF with reduced EF (HFrEF), 97 (21.4%) had HF with slightly reduced EF (HFmrEF) and 131 (28.9%) had HF with preserved EF (HFpEF). At the time of diagnosis of de novo HF, 28.9% were prescribed with ARNI, 28% with ACE inhibitors, 23.8% with ARBs, 82.6% with beta-blockers and 66.2% with SGLT-2 inhibitors. Stratifying the population by EF at the time of diagnosis, ARNI prescriptions were higher in HFrEF (50.7%) and HFmrEF (16.5%), and SGLT2 inhibitors were widely prescribed regardless of EF. Furthermore, a very high rate of beta-blocker prescription was observed in all HF phenotypes, especially in HFrEF (88.9%) and HFmrEF (90.7%). However, only 51.6% of patients with HFrEF were taking all four drug classes recommended by guidelines. At the time of the analysis, of the 453 patients enrolled, 115 had undergone a second evaluation, at a median follow-up of 2.6 months. Conclusions The preliminary results of the OptIMA-HF de novo registry show fair adherence in the prescription of individual guideline-recommended drugs in all HF phenotypes and a 4-drug combination therapy was prescribed in slightly more than half of HFrEF patients. These data support the importance of real-world studies to define therapeutic approach in conditions with limited scientific evidence and highlight the need for strategies to improve the implementation of pharmacological therapies in clinical practice, in order to improve patient’s long-term outcomes and slow the disease progression.