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

Q: What are the key findings of this study?

Sacubitril/valsartan improved LVEF from 27% to 30% (p<0.001) and reduced NYHA class III patients from 40% to 17% (p<0.001) in HFrEF patients over 10.5 months.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Heart failure with reduced ejection fraction (HFrEF) (n=205). Intervention: Sacubitril/valsartan vs. Baseline (pre-treatment values). Primary outcome: Left ventricular ejection fraction (LVEF) (p=<0.001).

Q: What does this research mean for the field?

Sacubitril/valsartan improves left ventricular ejection fraction and functional NYHA class while reducing NT-proBNP levels and diuretic requirements in patients with heart failure with reduced ejection fraction. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Q: What question did this study set out to answer?

To evaluate the impact of sacubitril/valsartan on clinical status, circulating biomarkers, and echocardiographic parameters of cardiac performance in patients with heart failure and reduced ejection fraction.

Giuseppe Romano; Giuseppe Vitale; Laura Ajello; Valentina Agnese; Diego Bellavia; Giuseppa Caccamo; Egle Corrado; Gabriele Di Gesaro; Calogero Falletta; Eluisa La Franca; Chiara Minà; Salvatore Antonio Storniolo; Filippo M. Sarullo; Francesco Clemenza

doi:10.3390/jcm8122165

December 6, 2019Journal of Clinical MedicineOpen Access

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

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Key result

Sacubitril/valsartan linked to an absolute ~3% improvement in LVEF in HFrEF over 10 months.

P<0.001
n=205

Figures

Why the study?

Sacubitril/valsartan reduces death and HF hospitalization, but its impact on cardiac performance remains limited.

Does sacubitril/valsartan improve clinical, biochemical, and echocardiographic parameters in patients with HFrEF?

Key Points

To evaluate the impact of sacubitril/valsartan on clinical status, circulating biomarkers, and echocardiographic parameters of cardiac performance in patients with heart failure and reduced ejection fraction.
Prospective observational study enrolling 216 patients with heart failure and reduced ejection fraction (mean age 59 ± 10 years, 46% ischemic heart disease).
Administered sacubitril/valsartan with follow-up evaluations over a median duration of 10.49 months (range 2.93–18.44 months) in 205 completing patients.
The proportion of patients in NYHA functional class III decreased from 40% to 17% (p < 0.001), while median NT-proBNP fell from 1865 ± 2318 to 1514 ± 2205 pg/mL (p = 0.01) alongside a decrease in mean furosemide dose from 131.3 ± 154.5 to 120 ± 142.5 mg (p = 0.047).
Left ventricular ejection fraction increased from 27 ± 5.9% to 30 ± 7.7% (p < 0.001) and E/A ratio improved from 1.67 ± 1.21 to 1.42 ± 1.12 (p = 0.002).
Moderate-to-severe mitral regurgitation decreased from 30.1% to 17.4% (p = 0.002), and tricuspid regurgitation velocity declined from 2.8 ± 0.55 m/s to 2.64 ± 0.59 m/s (p < 0.014).

Study Design

Type

Observational (n=205)

Blinding

Single-blind

Multicenter

No

Structured PICO

Does sacubitril/valsartan improve clinical, biochemical, and echocardiographic parameters in patients with HFrEF?

P

Population

205 stable patients with HFrEF (mean age 59 years, 15% female, LVEF <35%, NYHA class II-III on optimal ACE-I/ARB therapy), free of recent HF hospitalization or revascularization, followed for a median of 10.49 months.

I

Intervention

Sacubitril/valsartan

O

Outcome

Changes in clinical (NYHA class), biochemical (NT-proBNP), and echocardiographic parameters (ejection fraction, E/A ratio, mitral regurgitation, tricuspid velocity)surrogate

Main Result

Absolute Event Rate: 30% vs 27%

p-value: p=<0.001

Sacubitril/valsartan therapy in HFrEF patients is associated with significant reverse cardiac remodeling, biomarker reduction, and symptomatic improvement.

Limitations

Non-randomized study design
Relatively small sample size and lack of a control group
Use of echocardiography rather than cardiac MRI for LV volume assessment
Some echocardiographic parameters (LV mass index, strain analysis) were not performed
Mitral regurgitation was visually/qualitatively assessed without PISA or vena contracta measurements
Relatively short follow-up may have underestimated the magnitude of reverse remodeling

Implication

LVEF and NYHA improvements with sacubitril/valsartan in HFrEF; extends observational data but leaves open randomized confirmation.

Abstract

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.

Discussion

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Cite This Study

Romano et al. (2019) conducted an observational in Heart failure with reduced ejection fraction (HFrEF) (n=205). Sacubitril/valsartan vs. Baseline (pre-treatment values) was evaluated on Left ventricular ejection fraction (LVEF) (p=<0.001). Sacubitril/valsartan improved LVEF from 27% to 30% (p<0.001) and reduced NYHA class III patients from 40% to 17% (p<0.001) in HFrEF patients over 10.5 months.

synapsesocial.com/papers/6a7c9390e6f41aaf0bcf7ed5 https://doi.org/10.3390/jcm8122165

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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