NCT03745898终止3 期
The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea (LOFT-HF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 26
- 主要终点
- First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention
研究概览
简要总结
The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Aged ≥ 21 years at the date of consent.
- •History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 50% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
- •Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas).
- •New York Heart Association (NYHA) Class III or IV, or NYHA Class II with any of the following:
- •at least one hospitalization for heart failure within the 24 months prior to enrollment or;
- •a BMI corrected BNP ≥ 300 pg/ml or a corrected NT-proBNP ≥ 1500 pg/ml or;
- •an ED visit for HF exacerbation where the patient has received an IV diuretic within 12 months of enrollment.
- •Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization (reasons for intolerance to GDNT must be documented).
- •In the investigator's opinion, willing and able to comply with all study requirements.
- •Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent (including HIPAA authorization in the U.S.).
排除标准
- •Current positive airway pressure use or predominantly obstructive rather than central sleep apnea.
- •Oxygen saturation < 90% at rest during the day.
- •Nocturnal oxygen saturation < 88% for > 5 continuous minutes unaccompanied by apneas or hypopneas.
- •Chronic daytime or nighttime use of supplemental oxygen.
- •Participants and their bed-partners who currently smoke in the bedroom.
- •Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
- •Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
- •Transient ischemic attack or stroke within the previous 3 months.
- •Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
- •Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial.
- •Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
- •End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
- •Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
- •Life expectancy < 1 year for diseases unrelated to chronic HF.
- •Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
研究组 & 干预措施
Nocturnal Oxygen Therapy
Active Comparator
Active nocturnal oxygen therapy
干预措施: Oxygen (Drug)
Sham Nocturnal Oxygen Therapy
Sham Comparator
Sham nocturnal oxygen therapy (room air)
干预措施: Room Air (Other)
结局指标
主要结局
First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention
时间窗: 12 months
This is a composite primary outcome
次要结局
- Recurrent Event Analyses of Mortality and Morbidity(From enrollment to study termination, attrition or death. Min = 41 days, Max = 626 Days)
- Quality of Life and Symptoms - Depressive Symptoms(Baseline, 6 month follow up)
- Quality of Life and Symptoms - Sleep Symptoms and Sleep Related Daytime Impairment(Baseline, 6 month follow up)
- Quality of Life and Symptoms - HF Disease-specific Quality of Life(Baseline, 6 month follow up)
- Quality of Life and Symptoms - Generic-quality of Life(Baseline, 6 month follow up)
- Functional Status(Baseline, 6 month follow up)
研究者
Susan Redline
Professor and Senior Physician
Brigham and Women's Hospital
研究点 (26)
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