Multiple Cardiac Sensors for the Management of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 60
- 主要终点
- Manage-HF Phase I
研究概览
简要总结
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.
详细描述
Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.
Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 18 or above, or of legal age to give informed consent
- •Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
- •Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
- •Remotely monitored by LATITUDE 5.0 (or future versions)
- •Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
- •Meet at least one of the three following conditions:
- •At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
- •Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
- •N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
排除标准
- •The subject is unable to sign or refuses to sign the patient informed consent
- •Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
- •The subject is implanted with unipolar right atrial or right ventricular leads
- •Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
- •Subject is pregnant or planning to become pregnant during the study
- •Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)
- •Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
- •Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
- •A life expectancy of less than 12 months per clinician discretion
- •APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
- •APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.
结局指标
主要结局
Manage-HF Phase I
时间窗: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit
Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.
次要结局
未报告次要终点