Valutazione Della capacità d'Esercizio, Della funzionalità Respiratoria e Del Rimodellamento Ventricolare Sinistro in Pazienti Affetti da Scompenso Cardiaco a Frazione d'Eiezione Ridotta Trattati Con Sacubitril/Valsartan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- VO2 evaluation after treatment
研究概览
简要总结
Background: Sacubitril/valsartan, a novel therapy in the treatment of heart failure with reduced ejection fraction (HFrEF), has recently proved efficacy in improving exercise tolerance and cardiac performance. Cardiopulmonary exercise test (CPET) provides functional prognostic parameters for patient with HFrEF (i.e. peakVO2 and ventilation/CO2 production [VE/VCO2] slope) and it is a well-recognized, valuable, accurate tool for risk stratification.
Aim of the study and methods: The aim of the study is to prospectively enroll a cohort of 100 HFrEF outpatients eligible for sacubitril/valsartan and perform serial CPET, laboratory and echocardiographic assessments before and during the gradual titration of the treatment, in order to evaluate its effects on cardiopulmonary function and left ventricular remodeling. The procedures will be repeated along the follow-up at 1, 2 and 3 months after the enrollment (titration period) and at 6 months after the reach of the maximum tolerated dose.
详细描述
Given the recent introduction of the drug into the clinical routine, the evaluation of the experience "on the field" is important to refine the clinical management of patients treated with sacubitril / valsartan. Furthermore, at the moment sacubitril / valsartan has proven effective in some small preliminary studies in improving the ejection fraction and some echocardiographic parameters of ventricular remodeling on top of the concomitant optimal medical therapy, although further data are needed in this regard.
In particular, the potential benefits on exercise capacity, respiratory function parameters and left ventricular remodeling in heart failure patients treated with sacubitril / valsartan has not been studied extensively at the moment. In this regard, the cardiopulmonary exercise test (CPET) allows to obtain prognostic functional parameters in patients with chronic heart failure such as peak V02 (peak V02) and the ventilation / production of C02 slope (VE / VC02 slope). CPET is a valid, recognized and accurate tool for risk stratification in heart failure patients.
Furthermore, few data are available on lung diffusion (DLCO) and on specific markers of the alveolar-capillary membrane, such as type B surfactant proteins (SPB) in patients treated with sacubtril / valsartan. Our team has already shown how these biomarkers and DLCO are influenced by drug treatments such as Levosimendan and Ace inhibitors.
The aim of the study is to evaluate the exercise capacity, spirometry, echocardiographic parameters of left ventricular sistolic and diastolic function, Nt-proBNP dosage and quality of life and the related dose-effect correlation in a multicenter cohort of 100 patients with stable heart failure (class functional NYHA II e lII) and reduced left ventricular ejection fraction in patients eligible for sacubitril / valsartan treatment.
A subgroup of patients will be also analyzed for data relating to the effect of sacubitril / valsartan on DLCO and blood levels of Surfactant Bindig protein (SPB).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association Class (NYHA) II-III
- •stable clinical conditions
- •reduced ejection fraction (< 35%)
- •capability to perform a cardiopulmonary exercise test (CPET)
排除标准
- •moderate-severe chronic obstructive pulmonary disease
- •chronic oxygen therapy
- •contraindication to CPET
- •planned procedures (i.e. cardiac surgery, revascularization procedures, CRT implantation) that could per se impact on CPET, echocardiography and laboratory values
研究组 & 干预措施
Heart failure
outpatients with heart failure with reduced ejection fraction in treatment with sacubitril/valsartan according to guidelines
干预措施: Sacubitril-Valsartan (Drug)
结局指标
主要结局
VO2 evaluation after treatment
时间窗: 9 months after start of treatment with sacubitril/valsartan
changes in peak VO2 at cardiopulmonary exercise test
次要结局
- DLCO(9 months after start of treatment with sacubitril/valsartan)
- lung function evaluation after treatment(9 months after start of treatment with sacubitril/valsartan)
- left ventricular remodeling(9 months after start of treatment with sacubitril/valsartan)
- Surfactant B-type protein after treatment(9 months after start of treatment with sacubitril/valsartan)
研究者
Piergiuseppe Agostoni
Prof
Centro Cardiologico Monzino