SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 94
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo).
研究概览
简要总结
The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.
详细描述
This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.
For the purpose of this substudy, patients will be followed up for a period of 12 months.
The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:
- Echocardiogram (for both groups)
- cMRI (for both groups)
- PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)
- 4 questionnaires (for both groups)
- Additional blood testing (for both groups)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion and
排除标准
- •are mainly those applicable for the parent study; SERVE-HF. The inclusion and exclusion criteria are listed here.
- •INCLUSION CRITERIA FOR SERVE-HF STUDY:
- •Over 22 years of age
- •Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
- •Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
- •Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
- •Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
- •Optimised medical treatment according to the applicable guidelines
- •Able to provide informed consent
- •ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY
- •Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula
- •EXCLUSION CRITERIA FOR THE SERVE-HF STUDY:
- •Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
- •Oxygen saturation at rest during the day 90% at the time of inclusion
- •Current use of Positive Airway Pressure (PAP) therapy
- •Life expectancy < 1 year for diseases unrelated to chronic heart failure
- •Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
- •Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
- •Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
- •Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
- •Acute myocarditis/pericarditis within 6 months prior to randomisation
- •Untreated or therapy refractory Restless legs Syndrome (RLS)
- •Pregnancy
- •ADDITIONAL EXCLUSION CRITERIA FOR THE SUBSTUDY
- •Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
- •Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
研究组 & 干预措施
Optimal medical therapy according to guidelines
optimal medical therapy
Therapy with adaptive servo ventilation
optimal medical therapy + adaptive servoventilation
干预措施: adaptive servoventilation (ASV) (Device)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo).
时间窗: Baseline (Randomization), 6- and 12 month-Follow-up-visit
次要结局
- Changes in sleep-disordered breathing(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in left and right ventricular function(Baseline (Randomization), 6-and 12-month-Follow-up visit)
- Changes in LV systolic and diastolic indexed volumes(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in right ventricular (RV) systolic and diastolic indexed volumes(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in LV and RV mass(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in LV sphericity index and LV end-systolic global wall stress(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in sleep duration and sleep stages as well as arousals(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in mental status assessed by Mini-Mental State Examination (MMSE)(Baseline (Randomization), 6- and 12-month-Follow-up-visit)
- Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7(Baseline (Randomization), 6- and 12-month-Follow-up-visit)