Evaluation in Real Life Conditions of Sacubitril-valsartan Combination in Patients With Chronic Heart Failure and Sleep Apnea Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Changes in Apnea-Hypopnea Index as compared to baseline
研究概览
简要总结
Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS.
SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality.
The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.
详细描述
The Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Chronic HF provides almost 2% of health expenditure in developed countries, it is the largest expenditure item in the USA (34.8 billion dollars). In most developed countries, including France, mortality 1 year after diagnosis of chronic HF is 40%, it is 50% at 2 years, and over 70% at 4.5 years.
Sleep apnea syndrome (SAS) is frequently associated with HF in 20% to 75% of cases. The presence of an apnea syndrome is associated with a greater morbidity and mortality. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS : 6 studies corresponding to a total of 67 patients and 5 types of molecules reported an incomplete effect on the central component of the Apnea Hypopnea Index (AHI) for these patients.
SACUBITRIL - VALSARTAN (ENTRESTO®) is a new treatment of HF recently indicated class I, level B in the recent ESC guidelines 2016 on HF. It combines inhibitory prodrug neprilysin and valsartan. After initial failures with neprilysin inhibition alone or dual neprilysin-angiotensin converting enzyme (ACE) inhibition, the PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with the SACUBITRIL - VALSARTAN combination (formerly LCZ696). In comparison to the ACE inhibitor enalapril, sacubitril/valsartan reduced the occurrence of the primary end point (cardiovascular death or hospitalisation for HF) by 20% with a 16% reduction in all-cause mortality. These findings suggest that sacubitril/valsartan should replace an ACE inhibitor or angiotensin receptor blocker as the foundation of treatment of symptomatic patients (NYHA II-IV) with HF and a reduced ejection fraction.
The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN in CHF patients presenting sleep apnea syndrome. We speculate that synchronously of a beneficial effect on heart failure, the SACUBITRIL-VALSARTAN combination could improve an associated SAS and in particular the central component of the AHI index.
After an exhaustive initial pre-therapeutic evaluation, the SACUBITRIL-VALSARTAN combination treatment is initiated for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age is greater than or equal to 18 years
- •Patient with chronic heart failure (LVEF ≤ 45%).
- •Written informed consent
排除标准
- •Renal insufficiency (GF<30 milliliters/min)
- •Pregnancy
- •Allergy to one compound
- •Personal history of angiooedema
- •Hemodynamical instability
- •Severe hepatopathy
- •Current and not treated hyperkaliemia
- •Prognosis < 6months
- •Current CPAP or ASV treatment for Sleep Apnea Syndrome
研究组 & 干预措施
SACUBITRIL - VALSARTAN
SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) is a new treatment of HF recently indicated class I, level B in the recent ESC guidelines 2016 on HF. It combines inhibitory prodrug neprilysin and valsartan.
干预措施: SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) (Drug)
结局指标
主要结局
Changes in Apnea-Hypopnea Index as compared to baseline
时间窗: 0 month to 3 months
Changes in AHI as compared to baseline Measure of the apnea hypopnea index by a polygraphy performed before and after 3 months of treatment. The 2012 American Academy of Sleep Medicine recommendations are utilized in order to characterized apnea and hypopnea events, the central or obstructive or mixed phenotype
次要结局
- Subject Global Assessment(0 month to 3 months)
- NYHA Functional Class(0 month to 3 months)
- Heart Rhythm(0 month to 3 months)
- Systolic and diastolic Blood Pressure(0 month to 3 months)
- Renal function as compared to baseline (Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula(0 month to 3 months)
- BNP (B-type Natriuretic Peptide) rates(0 month to 3 months)
- Subject medications(0 month to 3 months)
- Quality of life as measured by Minnesota Living with Heart Failure Questionary(0 month to 3 months)
- Quality of life as measured by EQ-5D-3L Questionary(0 month to 3 months)
- Epworth Sleepiness Scale(0 month to 3 months)
- Pichot Fatigue Scale(0 month to 3 months)
- Type of device used in group 2 patients(0 month to 3 months)
- CPAP/ASV compliance in group 2 patients(0 month to 3 months)
- Historical of CPAP/ASV compliance in group 2 patients(0 month to 3 months)
- Settings of CPAP/ASV device used in group 2 patients(0 month to 3 months)
- Type of mask used in group 2 patients(0 month to 3 months)
- Historical use of mask in group 2 patients(0 month to 3 months)
- Changes in AHI compared to Baseline in group 2 patients(0 month to 3 months)