Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- ResMed
- 入组人数
- 126
- 试验地点
- 15
- 主要终点
- Global Rank Endpoint
研究概览
简要总结
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.
详细描述
This study is a randomized, unblinded, multi-center trial with parallel group design, with subjects randomized to either control (optimized medical therapy for chronic heart failure) or active treatment (optimized medical therapy plus use of MV-targeted ASV) in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 21 years or older
- •Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on admission without systolic blood pressure >180 mmHg or atrial fibrillation, or diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and ACE-inhibitors or ARBs for at least 4 weeks prior to admission
- •Hospital admission for acute decompensated HF as determined by:
- •Dyspnea at rest or with minimal exertion
- •AND At least two of the following signs and symptoms:
- •Orthopnea
- •Pulmonary rales beyond basilar
- •Chest congestion on x-ray
- •BNP≥300pg/mL or NT pro-BNP≥1200pg/mL
- •Pulmonary capillary wedge pressure (PCWP) ≥25mmHg during current hospitalization
- •Presented to hospital or clinic at least 24 hours prior to consent
- •Patient stable enough to stop oxygen use for duration of polygraphy test or have access to dual lumen cannula for polygraphy test
- •Sleep disordered breathing (SDB) documented by polygraphy with an AHI≥15 events/hour
- •Patient is able to fully understand study information and sign a consent form
排除标准
- •Right-sided heart failure without left-sided heart failure
- •Sustained systolic blood pressure <80 mmHg at baseline
- •Acute coronary syndrome within 1 months of randomization
- •Active myocarditis
- •Complex congenital heart disease
- •Constrictive pericarditis
- •Non-cardiac pulmonary edema
- •Clinical evidence of digoxin toxicity
- •Need for mechanical hemodynamic support at time of randomization
- •Oxygen saturation ≤85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
- •COPD exacerbation as the primary reason for hospital admission
- •Current use (within 4 weeks of study entry) of any PAP-therapy (eg, fixed, bi-level, or APAP)
- •Life expectancy < 1 year for diseases unrelated to HF
- •Transient ischemic attack (TIA) or Stroke within 3 months prior to randomization
- •CABG procedure within 3 months prior to randomization, or planned to occur during study period
- •CRT implant within 3 months prior to randomization , or planned to occur during study period
- •VAD implant planned to occur during study period
- •Heart transplant list Status 1a or 1b
- •Status post-transplant or LVAD
- •Prescribed inotrope therapy anticipated at discharge
- •Chronic Dialysis
- •Known amyloidosis, hypertrophic obstructive cardiomyopathy, arteriovenous fistulas
- •Primary hemodynamically significant uncorrected valvular heart disease (obstructive or regurgitant) with planned intervention within 6 months of randomization
- •Pregnant, or planning to become pregnant
- •Cannot tolerate ASV treatment during run-in
- •Cannot perform 6MWT at baseline
- •Occupation as a commercial driver or pilot and plan to be performing these activities during the study period
- •Inability to comply with planned study procedures
- •Participation in pharmaceutical or treatment-related clinical study within 1 month of study enrollment
研究组 & 干预措施
MV ASV+OMT
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
干预措施: MV ASV (Device)
MV ASV+OMT
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
干预措施: Optimized Medical Treatment (Drug)
OMT only
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
干预措施: Optimized Medical Treatment (Drug)
结局指标
主要结局
Global Rank Endpoint
时间窗: Baseline, 6 months
A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Change from Baseline to 6 months)
- Six-minute Walk Distance(Change from Baseline to 6 months)
- NT Pro-BNP(Change from Baseline to 6 months)
- ECHO Parameters - LVEF(Change from Baseline to 6 months)
- ECHO Parameters - LVESVI(Change from Baseline to 6 months)
- Biomarkers - Inflammation(Change from Baseline to 6 months)
- Biomarkers - Cardiovascular(Change from Baseline to 6 months)
- Biomarkers - Renal Function(Change from Baseline to 6 months)
- ECHO Parameters - E/e' Ratio(Change from Baseline to 6 months)
- Win Ratio(6 months)
- Sleep Parameters(Change from Baseline to 6 months)
- Number of Subjects With HF Hospitalization(2 days, 1 week, 1, 2, 3, and 6 months)
- EQ-5D-5L Index(Change from Baseline to 6 months)
- PSQI(Change from Baseline to 6 months)
- ESS(Change from Baseline to 6 months)
- Death(2 days, 1 week, 1, 2, 3, and 6 months)
- Time Dead/Hospitalized(6 months)
- DASI(Change from Baseline to 6 months)
- PHQ-9(Change from Baseline to 6 months)