Association of SGLT2i treatment with functional capacity in patients with or without type 2 diabetes mellitus with heart failure and reduced ejection fraction

Abstract

Background: Heart failure (HF) is a serious and common condition in clinical practice. The estimated prevalence of HF in developed countries in the adult population is 2% and increases to 10% in the elderly. HF is the leading cause of hospitalization in the United States and Europe. It implies a high economic cost for the health system and a great loss of quality of life. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) were initially developed for the treatment of diabetes mellitus due to their hypoglycaemic activity. Around 40% of HF patients have type 2 Diabetes Mellitus (T2DM). SGLT2i show metabolic and hemodynamic effects, which justify their efficacy in T2DM and HF treatment. They have shown, in several studies like DAPA-HF or EMPEROR-reduced, to reduce cardiovascular and all-cause mortality and HF hospitalization in diabetic and non-diabetic patients. So, they have become a first-line treatment in HF with reduced ejection fraction (HFrEF) according to the ESC Guidelines 2021. The cardiorenal benefits cannot be explained by an action of SGLT2 inhibitors to lower blood glucose, since similar effects have not been seen with other antidiabetic drugs that have greater antihyperglycemic actions. Some of the hypothetic mechanisms are the osmotic diuresis they generate and the reduction of interstitial oedema in a secondary way, together with direct mechanisms on the myocyte at the level of the NHE-1 cotransporter, among others. Objectives: The main objective is to assess changes in the exertional capacity or functional capacity of patients by ergospirometry, studying the change in the values of ventilatory thresholds, O2 consumption and VE/VCO2 slope, after SGLT2i treatment. Thus, we intend to achieve the improvement in the optimization of this treatment. Design: A longitudinal, observational, descriptive and prospective study, without a control group, will be performed to describe the association between SGLT2i and functional capacity and cardiac function in patients with HF and reduced left ventricular ejection fraction (LVEF). It will be carried out in Hospital Santa Caterina of Girona between February 2022 and April 2022. Participants: Patients > 18 years old, with a diagnosis of HF with reduced LVEF (<40%), with or without type 2 DM, who are in follow-up in the cardiology consultations of Santa Caterina Hospital of Girona. Methods: a non-probabilistic consecutive sampling will be used in this study, with a sample of 196 patients. We will study functional capacity by ergospirometry and a quality of life questionnaire (Minnesota) and cardiac function by echocardiogram and NT-proBNP values

Background: Heart failure (HF) is a serious and common condition in clinical practice. The estimated prevalence of HF in developed countries in the adult population is 2% and increases to 10% in the elderly. HF is the leading cause of hospitalization in the United States and Europe. It implies a high economic cost for the health system and a great loss of quality of life. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) were initially developed for the treatment of diabetes mellitus due to their hypoglycaemic activity. Around 40% of HF patients have type 2 Diabetes Mellitus (T2DM). SGLT2i show metabolic and hemodynamic effects, which justify their efficacy in T2DM and HF treatment. They have shown, in several studies like DAPA-HF or EMPEROR-reduced, to reduce cardiovascular and all-cause mortality and HF hospitalization in diabetic and non-diabetic patients. So, they have become a first-line treatment in HF with reduced ejection fraction (HFrEF) according to the ESC Guidelines 2021. The cardiorenal benefits cannot be explained by an action of SGLT2 inhibitors to lower blood glucose, since similar effects have not been seen with other antidiabetic drugs that have greater antihyperglycemic actions. Some of the hypothetic mechanisms are the osmotic diuresis they generate and the reduction of interstitial oedema in a secondary way, together with direct mechanisms on the myocyte at the level of the NHE-1 cotransporter, among others. Objectives: The main objective is to assess changes in the exertional capacity or functional capacity of patients by ergospirometry, studying the change in the values of ventilatory thresholds, O2 consumption and VE/VCO2 slope, after SGLT2i treatment. Thus, we intend to achieve the improvement in the optimization of this treatment. Design: A longitudinal, observational, descriptive and prospective study, without a control group, will be performed to describe the association between SGLT2i and functional capacity and cardiac function in patients with HF and reduced left ventricular ejection fraction (LVEF). It will be carried out in Hospital Santa Caterina of Girona between February 2022 and April 2022. Participants: Patients > 18 years old, with a diagnosis of HF with reduced LVEF (<40%), with or without type 2 DM, who are in follow-up in the cardiology consultations of Santa Caterina Hospital of Girona. Methods: a non-probabilistic consecutive sampling will be used in this study, with a sample of 196 patients. We will study functional capacity by ergospirometry and a quality of life questionnaire (Minnesota) and cardiac function by echocardiogram and NT-proBNP values