Effects of sacubitril/valsartan on the functional capacity of real-world patients in Italy: the REAL.IT study on heart failure with reduced ejection fraction.

Sarullo FM; U.O.S.D. di Riabilitazione Cardiovascolare Ospedale Buccheri La Ferla Fatebenefratelli, Palermo, Italy.
Nugara C; Sarullo S; Iacoviello M; Di Gesaro G; Miani D; Driussi M; Correale M; Bilato C; Passantino A; Carluccio E; Villani A; Degli Esposti L; D’Agostino C; Peruzzi E; Poli S; Di Lenarda A;

Frontiers in cardiovascular medicine [Front Cardiovasc Med] 2024 May 10; Vol. 11, pp. 1347908.
Date of Electronic Publication: 2024 May 10 (Print Publication: 2024).

Background: Heart failure (HF) significantly affects the morbidity, mortality, and quality of life of patients. New therapeutic strategies aim to improve the functional capacity and quality of life of patients while controlling HF-related risks. Real-world data on both the functional and cardiopulmonary exercise capacities of patients with HF with reduced ejection fraction upon sacubitril/valsartan use are lacking.
Methods: A multicenter, retrospective, cohort study, called REAL.IT, was performed based on the data collected from the electronic medical records of nine specialized HF centers in Italy. Cardiopulmonary exercise testing was performed at baseline and after 12 months of sacubitril/valsartan therapy, monitoring carbon dioxide production (VCO 2 ) and oxygen consumption (VO 2 ).
Results: The functional capacities of 170 patients were evaluated. The most common comorbidities were hypertension and diabetes (i.e., 53.5 and 32.4%, respectively). At follow-up, both the VO 2 peak (from 15.1 ± 3.7 ml/kg/min at baseline to 17.6 ± 4.7 ml/kg/min at follow-up, p  < 0.0001) and the predicted % VO 2 peak (from 55.5 ± 14.1 to 65.5 ± 16.9, p  < 0.0001) significantly increased from baseline. The VO 2 at the anaerobic threshold (AT-VO 2 ) increased from 11.5 ± 2.6 to 12.5 ± 3.3 ml/kg/min ( p  = 0.021), and the rate ratio between the oxygen uptake and the change in work (ΔVO 2 /Δwork slope) improved from 9.1 ± 1.5 to 9.9 ± 1.6 ml/min/W ( p  < 0.0001).
Conclusions: Sacubitril/valsartan improves the cardiopulmonary capacity of patients with HFrEF in daily clinical practice in Italy.
Competing Interests: MI: Lectures or consultant for Novartis, Vifor Pharma, Boehringer, Lilly, Bayer, AstraZeneca, Roche Diagnostics, Neopharmed Gentili. ADL: Lectures for Novartis, Vifor Pharma, Boheringer, Daiichi, Bayer, Pfizer, AstraZeneca, Research Funds from Novartis, Amgen, AstraZeneca, Vifor Pharma, Bayer. CDA, EP, and SP are employees of Novartis. LDE was employed by company CliCon S.r.l. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision. The authors declare that this study received funding from Novartis Farma. The funder had the following involvement in the study: study design, data collection and analysis, supporting manuscript preparation.