Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Analyze the changes in the T-wave alternans
研究概览
简要总结
The aim of this study is to know if the Sacubitril-Valsartan treatment improves the T-wave alternans in those patients that begin its treatment, which would indirectly show a lower risk of malignant ventricular arrythmias.
详细描述
Sacubitril-Valsartan has shown to reduce sudden death in its principal clinical trial, PARADIGM-HF.
A T wave alternans (TWA) is an electrophysiological phenomenon that acts as an independent predictor of sudden death and ventricular arrhythmias in postinfarct myocardial.
TWA is measured by using a special software and electrodes during a treadmill test, that analyse small changes in the microvolt of the T wave consecutive with a complex algorithm in three dimensions. The TWA could be negative (normal), positive (pathological) or indeterminate. If a TWA is pathological it reflects an electric instability in depolarization.
Our hypothesis is that the treatment with Sacubitril-Valsartan in heart failure patients with reduced ejection fraction, could improved the TWA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adults from 18 to 80 years old.
- •Patients with grade II heart failure according to the New York Heart Association (NYHA).
- •Left systolic disfunction: left ventricle ejection fraction<40%
- •NT-proBNP > 600 pg/ml (or > 100 pg/ml in the case the patients has been hospitalised during the last year.
- •Treated with ACE or ARA II+betablocker at stable doses during the prior 4 weeks to the beginning of the study.
排除标准
- •Previously treated with Sacubitril-Valsartan.
- •Allergy or intolerance to ARA II.
- •Systolic blood pressure < 100 mmHG at inclusion.
- •Glomerular Filtration <35 ml / min / 1.73 m2 of body surface.
- •Level of potassium > 5,4 mEq/l.
- •Impossibility to walk on a treadmill.
- •Record of recovered sudden death or documented ventricular tachycardia.
- •Carrier of an automatic implantable defibrillator.
研究组 & 干预措施
Sacubitril-Valsartan cohort
Patients with left systolic disfunction (left ventricle ejection fraction<40%) heart failure and diagnosed with grade II heart failure that have been treated with an ACE or ARA II+betablocker at stable doses during the last 4 weeks and after being evaluated by the cardiologist start Sacubitril-Valsartan treatment.
干预措施: Sacubitril-Valsartan (Drug)
结局指标
主要结局
Analyze the changes in the T-wave alternans
时间窗: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Comparison of the results in the same patient just before the beginning of the Sacubitril-Valsartan pharmacological treatment versus 6 months after its beginning, in patients with grade II heart failure and left systolic disfunction (left ventricle ejection fraction\<40%).
次要结局
- Study the levels of the n-terminal type B natriuretic propeptide(Up to 6 months after the beginning of the Sacubitril-Valsartan treatment)
- Evaluate the echocardiographic results(Up to 6 months after the beginning of the Sacubitril-Valsartan treatment)
- Evaluate the results in the life quality questionnaire.(Up to 6 months after the beginning of the Sacubitril-Valsartan treatment)