Early Effects of Sacubitril/Valsartan on Exercise Tolerance in Patients with Heart Failure with Reduced Ejection Fraction

Vitale, Giuseppe; Romano, Giuseppe; Caccamo, Giuseppa; Nugara, Cinzia; Ajello, Laura; Storniolo, Salvo; Sarullo, Silvia; Agnese, Valentina; Giallauria, Francesco; Novo, Giuseppina; Clemenza, Francesco; Sarullo, Filippo M

doi:10.3390/jcm8020262

Cited by 45 publications

(44 citation statements)

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“…These data are in line with our previously published results showing a significant improvement in well-known surrogates of cardiac performance such as peak VO 2 and O 2 pulse as well as others main prognostic-relevant CPET parameters after initiation of sacubitril/valsartan [16].…”

Section: Discussionsupporting

confidence: 92%

The Effects of Sacubitril/Valsartan on Clinical, Biochemical and Echocardiographic Parameters in Patients with Heart Failure with Reduced Ejection Fraction: The “Hemodynamic Recovery”

Romano

Vitale

Ajello

et al. 2019

JCM

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Background: Sacubitril/valsartan has been shown to be superior to enalapril in reducing the risks of death and hospitalization for heart failure (HF). However, knowledge of the impact on cardiac performance remains limited. We sought to evaluate the effects of sacubitril/valsartan on clinical, biochemical and echocardiographic parameters in patients with heart failure and reduced ejection fraction (HFrEF). Methods: Sacubitril/valsartan was administered to 205 HFrEF patients. Results: Among 230 patients (mean age 59 ± 10 years, 46% with ischemic heart disease) 205 (89%) completed the study. After a follow-up of 10.49 (2.93 ± 18.44) months, the percentage of patients in New York Heart Association (NYHA) class III changed from 40% to 17% (p < 0.001). Median N–Type natriuretic peptide (Nt-proBNP) decreased from 1865 ± 2318 to 1514 ± 2205 pg/mL, (p = 0.01). Furosemide dose reduced from 131.3 ± 154.5 to 120 ± 142.5 (p = 0.047). Ejection fraction (from 27± 5.9% to 30 ± 7.7% (p < 0.001) and E/A ratio (from 1.67 ± 1.21 to 1.42 ± 1.12 (p = 0.002)) improved. Moderate to severe mitral regurgitation (from 30.1% to 17.4%; p = 0.002) and tricuspid velocity decreased from 2.8 ± 0.55 m/s to 2.64 ± 0.59 m/s (p < 0.014). Conclusions: Sacubitril/valsartan induce “hemodynamic recovery” and, consistently with reduction in Nt-proBNP concentrations, improve NYHA class despite diuretic dose reduction.

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Section: Discussionsupporting

confidence: 92%

The Effects of Sacubitril/Valsartan on Clinical, Biochemical and Echocardiographic Parameters in Patients with Heart Failure with Reduced Ejection Fraction: The “Hemodynamic Recovery”

Romano

Vitale

Ajello

et al. 2019

JCM

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“…Of these, PROs (if derived from validated HF‐related quality of life instruments) and objective patient relevant measures of functional limitation [such as peak oxygen consumption (peak VO 2 ) or 6 min corridor walk test distance] are considered potentially approvable, whereas haemodynamic and biomarker endpoints are not. Despite this, few of the established HF therapies have been shown to improve either PROs or functional capacity 1–3 …”

Section: Introductionmentioning

confidence: 99%

A comprehensive individual patient data meta‐analysis of the effects of cardiac contractility modulation on functional capacity and heart failure‐related quality of life

et al. 2020

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Aims Cardiac contractility modulation, also referred to as CCM ™ , has emerged as a promising device treatment for heart failure (HF) in patients not indicated for cardiac resynchronization therapy. We performed a comprehensive individual patient data meta-analysis of all non-confounded prospective randomized controlled trials of CCM vs. control that have measured functional capacity and/or quality of life questionnaires in patients with HF. Methods and results The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in January 2020 to identify eligible randomized controlled trials. We also asked the sole manufacturer of the device for their list of known trials. Primary outcomes of interest were peak oxygen consumption (peak VO 2), 6 min walk test distance, and quality of life measured by Minnesota Living with Heart Failure Questionnaire (MLWHFQ), and all data were received as individual patient and individual time point data-points. Mean differences and 95% confidence intervals (CIs) were calculated for continuous data using a fixed-effects model. Five trials were identified, four randomized studies enrolling 801 participants for all endpoints of interest, and for peak VO 2 alone (n = 60), there was an additional single arm non-randomized trial (FIX-HF-5C2) with a prospective comparison of its 24 week peak VO 2 data compared with the control group of the FIX-HF-5C control patients. Pooled analysis showed that, compared with control, CCM significantly improved peak VO 2 (mean difference +0.93, 95% CI 0.56 to 1.30 mL/kg/min, P < 0.00001), 6 min walk test distance (mean difference +17.97, 95% CI 5.48 to 30.46 m, P = 0.005), and quality of life measured by MLWHFQ (mean difference À7.85, 95% CI À10.76 to À4.94, P < 0.00001). As a sensitivity analysis, we excluded the FIX-HF-5C2 trial (only relevant for peak VO 2), and the result was similar, mean difference +0.65, 95% CI 0.21 to 1.08 mL/kg/min, P = 0.004. Conclusions This comprehensive meta-analysis of individual patient data from all known randomized trials has shown that CCM provides statistically significant and clinically meaningful benefits in measures of functional capacity and HF-related quality of life.

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“…Second, we have not evaluated the quality of life with validated scales. Despite this, patients reported rapid and substantial functional improvement, as observed in another study …”

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confidence: 57%

Response to: Medical journals and editorial quality control by Erviti et al.

2019

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Early Effects of Sacubitril/Valsartan on Exercise Tolerance in Patients with Heart Failure with Reduced Ejection Fraction

Cited by 45 publications

References 32 publications

The Effects of Sacubitril/Valsartan on Clinical, Biochemical and Echocardiographic Parameters in Patients with Heart Failure with Reduced Ejection Fraction: The “Hemodynamic Recovery”

The Effects of Sacubitril/Valsartan on Clinical, Biochemical and Echocardiographic Parameters in Patients with Heart Failure with Reduced Ejection Fraction: The “Hemodynamic Recovery”

A comprehensive individual patient data meta‐analysis of the effects of cardiac contractility modulation on functional capacity and heart failure‐related quality of life

Response to: Medical journals and editorial quality control by Erviti et al.

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