Abstract:Aims Optimizing medical cardiac treatment for sleep apnoea (SA) in patients with chronic heart failure and reduced ejection fraction (HFrEF) is an expert Grade C recommendation based on six studies encompassing a total of 67 patients only. Whether sacubitril-valsartan (SV), a cornerstone of HFrEF medical treatment, impacts SA is unknown and requires evaluation.
Methods and resultsThe ENTRESTO-SAS trial is a six-centre, prospective, open-label real-life cohort study (NCT02916160). Ambulatory patients eligible f… Show more
“…The purpose of the present observational study was to evaluate the effects of sac/val on AHI, as well as on other clinical, functional and bio-humoral parameters patients affected by HFrEF and SA syndrome, under treatment with CPAP. In this regard, the ENTRESTO-SAS study has already shown that treatment with sac/val of patients with HFrEF and respiratory sleep disorders, induced significant AHI improvements after 3 months of therapy (39). Differently from the ENTRESTO-SAS study, our investigation was extended to 6 months, and was based not only on AHI evaluation, but also on polysomnography, as well as on the assessment of several other clinical, echocardiographic, and laboratory parameters.…”
Background
Heart failure with reduced ejection fraction (HFrEF) is a clinical condition frequently diagnosed in clinical practice. In patients affected by HFrEF, sleep apnea (SA) can be detected among the most frequent comorbidities. Sacubitril–valsartan (sac/val) association has been proven to be effective in reducing disease progression and all-cause mortality in HFrEF patients. Sac/val treatment can potentially attenuate SA development via several pathophysiologic mechanisms, including improvement of global hemodynamics, reduction of extracellular fluid overload, and decrease of sympathetic neural activity.
Purpose
The aim of this work is to evaluate the effects of a 6-month therapy with sac/val on hemodynamic and metabolic parameters, as well as on the occurrence of apnea/hypopnea and oxygen saturation in patients with HFrEF and SA, already treated with CPAP.
Methods
We recruited 132 patients affected by HFrEF and SA, already under treatment with continuous positive airway pressure (CPAP), which was discontinued 24 hours before the scheduled study timepoints. Physical examination, echocardiography, nocturnal cardio-respiratory monitoring, and laboratory tests were performed in each patient at baseline and after a 6-month treatment with sac/val.
Results
After 6 months, sac/val induced statistically significant changes in clinical, hemodynamic, biohumoral (NT-proBNP, serum electrolytes, creatinine and uric acid), and echocardiographic parameters. In particular, cardiac index (CI), both atrial and ventricular volumes and global longitudinal strain (GLS) improved. Moreover, polysomnography, carried out during a temporary CPAP interruption, revealed a significant reduction in global apnea-hypopnea index (AHI) value (p<0.0001), central AHI (p<0.0001), obstructive AHI (p<0.0001), oxygen desaturation index (ODI) (p<0.0001), and percentage time of saturation below 90% (TC90) (p<0.0001). The changes of CI, estimated glomerular filtration rate (eGFR), NT-proBNP and tricuspid annular plane excursion (TAPSE) contributed to 23.6%, 7.6%, 7.3% and 4.8% of AHI variability, respectively, and the whole model accounted for a 43.3% of AHI variation.
Conclusions
Our results suggest that treatment with sac/val is able to significantly improve the cardiorespiratory performance of patients with HFrEF and SA, integrating the positive impact of CPAP. Thus, both CPAP and sac/val therapy may synergistically contribute to lower the risks of both cardiac and pulmonary complications in HFrEF patients with SA.
Funding Acknowledgement
Type of funding sources: None.
“…The purpose of the present observational study was to evaluate the effects of sac/val on AHI, as well as on other clinical, functional and bio-humoral parameters patients affected by HFrEF and SA syndrome, under treatment with CPAP. In this regard, the ENTRESTO-SAS study has already shown that treatment with sac/val of patients with HFrEF and respiratory sleep disorders, induced significant AHI improvements after 3 months of therapy (39). Differently from the ENTRESTO-SAS study, our investigation was extended to 6 months, and was based not only on AHI evaluation, but also on polysomnography, as well as on the assessment of several other clinical, echocardiographic, and laboratory parameters.…”
Background
Heart failure with reduced ejection fraction (HFrEF) is a clinical condition frequently diagnosed in clinical practice. In patients affected by HFrEF, sleep apnea (SA) can be detected among the most frequent comorbidities. Sacubitril–valsartan (sac/val) association has been proven to be effective in reducing disease progression and all-cause mortality in HFrEF patients. Sac/val treatment can potentially attenuate SA development via several pathophysiologic mechanisms, including improvement of global hemodynamics, reduction of extracellular fluid overload, and decrease of sympathetic neural activity.
Purpose
The aim of this work is to evaluate the effects of a 6-month therapy with sac/val on hemodynamic and metabolic parameters, as well as on the occurrence of apnea/hypopnea and oxygen saturation in patients with HFrEF and SA, already treated with CPAP.
Methods
We recruited 132 patients affected by HFrEF and SA, already under treatment with continuous positive airway pressure (CPAP), which was discontinued 24 hours before the scheduled study timepoints. Physical examination, echocardiography, nocturnal cardio-respiratory monitoring, and laboratory tests were performed in each patient at baseline and after a 6-month treatment with sac/val.
Results
After 6 months, sac/val induced statistically significant changes in clinical, hemodynamic, biohumoral (NT-proBNP, serum electrolytes, creatinine and uric acid), and echocardiographic parameters. In particular, cardiac index (CI), both atrial and ventricular volumes and global longitudinal strain (GLS) improved. Moreover, polysomnography, carried out during a temporary CPAP interruption, revealed a significant reduction in global apnea-hypopnea index (AHI) value (p<0.0001), central AHI (p<0.0001), obstructive AHI (p<0.0001), oxygen desaturation index (ODI) (p<0.0001), and percentage time of saturation below 90% (TC90) (p<0.0001). The changes of CI, estimated glomerular filtration rate (eGFR), NT-proBNP and tricuspid annular plane excursion (TAPSE) contributed to 23.6%, 7.6%, 7.3% and 4.8% of AHI variability, respectively, and the whole model accounted for a 43.3% of AHI variation.
Conclusions
Our results suggest that treatment with sac/val is able to significantly improve the cardiorespiratory performance of patients with HFrEF and SA, integrating the positive impact of CPAP. Thus, both CPAP and sac/val therapy may synergistically contribute to lower the risks of both cardiac and pulmonary complications in HFrEF patients with SA.
Funding Acknowledgement
Type of funding sources: None.
“…Those eligible for dapagliflozin treatment and treated in real-life conditions will be invited to participate. Following the inclusion and exclusion criteria, a pre-therapeutic evaluation will be conducted [physical examination, echocardiography, laboratory testing, Minnesota Living with Heart Failure Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D), Epworth Sleepiness Scale, nocturnal ventilatory polygraphy] [ 20 ]. Fig.…”
Section: Methodsmentioning
confidence: 99%
“…Few studies have reported the pharmacological treatment of sleep apnea especially with heart failure [ 18 – 20 ]. We hypothesized that dapagliflozin, as a new star in the treatment of heart failure, could improve sleep apnea in heart failure patients.…”
Background
Heart failure with reduced ejection fraction (HFrEF) is associated with sleep dyspnea (SDB), which plays an adverse role in the pathophysiology of the condition. SDB management in HFrEF, however, remains controversial. HFrEF’s medical management has recently made significant progress with the discovery of new therapeutic avenues, namely sodia-glucose cotransporter-2 (SGLT-2) inhibitors, and better treatment of co-morbidities. Dapagliflozin, one of the SGLT-2 inhibitors, is a good candidate for correcting SDB of HFrEF patients because their known mechanisms of action are likely to counteract the pathophysiology of SDB in HFrEF.
Methods/design
The trial is a 3-month, multicentric, prospective, randomized controlled clinical study. Patients (i.e., adults with left ventricular ejection fraction ≤ 40%, Apnoea–Hypopnoea Index ≥ 15) will be randomized to receive optimized heart failure therapy plus a standard dose of dapagliflozin, while the control group will receive only optimized heart failure therapy. Patients will be evaluated before and after 3 months (nocturnal ventilatory polygraphy, echocardiography, laboratory testing, and quality-of-life and SDB questionnaires). The primary outcome is the change in the Apnoea–Hypopnoea Index, before and after 3 months of treatment.
Trial registration
www.chictr.org.cn, ChiCTR2100049834. Registered 10 August 2021.
“…Those eligible for dapagli ozin treatment and treated in real-life conditions will be invited to participate. Following the inclusion and exclusion criteria, a pre-therapeutic evaluation will be conducted [physical examination, echocardiography, laboratory testing, Minnesota Living with Heart Failure Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D), Epworth Sleepiness Scale, nocturnal ventilatory polygraphy] 20 .…”
Section: Methodsmentioning
confidence: 99%
“…Few studies have reported the pharmacological treatment of sleep apnea especially with heart failure [18][19][20] . For type 2 diabetes patients complicated with OSAHS, dapagli ozin not only improves blood glucose, blood pressure, blood lipids and weight loss, but also improves ventilation function.…”
Background: Heart failure with reduced ejection fraction (HFrEF) is associated with sleep disapnea (SDB), which plays an adverse role in the pathophysiology of the condition. SDB management in HFrEF, however, remains controversial. HFrEF's medical management has recently made significant progress with the discovery of new therapeutic avenues, namely sodia-glucose cotransporter-2 (SGLT-2) inhibitors, and better treatment of co-morbidities. Dapagliflozin, one of the SGLT-2 inhibitors, is a good candidate for correcting SDB of HFrEF patients because their known mechanisms of action are likely to counteract the pathophysiology of SDB in HFrEF.
Methods/design: The trial is a 3-month, multicentric, prospective, randomized controlled clinical study. Patients (i.e. adults with left ventricular ejection fraction≤40%, Apnoea–Hypopnoea Index≥15) will be randomized to receive optimized heart failure therapy plus a standard dose of dapagliflozin while the control group will receive only optimized heart failure therapy. Patients will be evaluated before and after 3 months(nocturnal ventilatory polygraphy, echocardiography, laboratory testing, and quality-of-life and SDB questionnaires). The primary outcome is the change in the Apnoea–Hypopnoea Index, before and after 3 months of treatment.
Trial registration: www.chictr.org.cn, ChiCTR2100049834. Registered 10 August 2021.
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