Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 554
- 试验地点
- 36
- 主要终点
- Primary safety endpoint: device-related complications
研究概览
简要总结
Randomized, parallel group controlled study examines the effect of supporting the Heart failure supply through pulmonary arterial (PA) pressure measurement with the CardioMEMS™ HF system to hard endpoints, safety and quality of life. The target population consists of heart failure (HF) patients who have been predominantly in New York Heart Association (NYHA) Stage III for the past 30 days and at least once in the past 12 months for HF were admitted to hospital. All patients receive basic care, which is based on structured telephone contact (between the care center, patient and family doctor) to optimize guideline compliant therapy. In the intervention group a PA pressure sensor is (CardioMEMS™-HF Sensor) implanted. These patients are structured by specially trained non-medical personnel aftercare with additional inclusion of the PA pressure values: adjusted to the basis of the information collected in PA monitoring the therapy is optimized. The follow-up period until the primary endpoint is 12 months.
In addition, data on longtime-mortality is being collected towards the end of the study for all study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Written consent received from the patient or a legal representative after the in-formation has been provided.
- •≥ 18 years of age.
- •Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study.
- •Objectified HF diagnosis for more than three months.
- •Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
- •Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
- •Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosed within 6 months prior to inclusion) must be treated with guideline-compliant HF pharmacotherapy; if one class of guideline-compliant medication is not tolerated, appropriate documentation must be supplied; patients must receive and tolerate at least one class of guideline-compliant medication; if no guideline-compliant medication is tolerated at all, the patient may not participate in the study.
- •In patients with preserved LVEF (>40%; diagnosed within 6 months prior to inclu-sion) comorbidities must be treated in accordance with guideline-compliant medi-cation.
- •Chest circumference (measured at axillary level) of less than 165 cm if BMI >35 kg/m
- •Willing and mentally and physically able to meet the requirements for follow-up and long-term basic care (this includes the long-term willingness of the patient, and of their relatives where relevant, to participate in PA pressure-based monitor-ing).
- •Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) .
排除标准
- •Enrolment in another study with an active treatment arm.
- •Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
- •Therapy-refractory heart failure in ACC/AHA stage D or new therapies that have taken place or are planned in the next 12 months (e.g. implantation of a left ven-tricular assist system / transplantation)
- •Active infection.
- •History of recurrent (>1 episode) pulmonary embolism and/or deep vein throm-bosis.
- •Continuous or intermittent chronic inotropic therapy.
- •Estimated glomerular filtration rate (eGFR) <25 ml/min
- •Life expectancy (according to the study physician's assessment) <12 months.
- •Severe, unrepaired congenital heart defect that would prevent implantation of the sensor.
- •Severe valve vitium with planned intervention in the next 3 months
- •Presence of a mechanical right heart valve.
- •Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent.
- •Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program.
- •Women of childbearing age with a positive pregnancy test at the time of inclusion
- •For the intervention group: Preliminary investigations have shown that the diameter of the pulmonary artery branch intended for implantation is <7 mm
- •The patient has private health insurance
研究组 & 干预措施
Control Group
Monitoring and therapy adjustment within the scope of the basic care described in the clinical trial plan.
Intervention Group
As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted.
干预措施: CardioMEMSTM HF sensor - pulmonary artery pressure measurement (Device)
结局指标
主要结局
Primary safety endpoint: device-related complications
时间窗: 12 months
Rate of Device / System related complications
Primary efficacy endpoint: composite of unplanned HF-related rehospitalisations and all-cause death
时间窗: 12 months
Composite endpoint of number of unplanned HF-related rehospitalisations or all-cause death
Co-primary safety endpoint: sensor failure
时间窗: 12 months
Rate of sensor failures
次要结局
- Longterm-mortality(From date of randomization of the first patient until date of study termination of the last patient (observation time: between 12 and up to 62 months))
- All-cause Mortality(12 months)
- Major secondary endpoint: changes in disease-related quality of life(6 and 12 months)
- Changes in generic health-related quality of life(6 and 12 months)
- HF-related mortality(12 months)
- Cardiovascular Mortality(12 months)
- Non-serious Adverse Events(12 months)
- Unplanned all-cause hospitalizations(12 months)
- Unplanned HF-related hospitalizations(12 months)
- Unplanned cardiovascular-related hospitalizations(12 months)
- Unplanned hospitalizations, other(12 months)
- Serious Adverse Events(12 months)
- Symptoms of heart failure(12 months)