SURPASS-HF: Safety and Utility of Remote Pulmonary Artery Sensor Shared-management in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Hospitalization(s)
研究概览
简要总结
SURPASS-HF was a 90-day, single-center, single-arm, prospective feasibility study asking whether adults with heart failure and an implanted pulmonary artery (PA) pressure sensor can safely share in managing their own diuretic (water pill) dosing. Participants were already implanted with a CardioMEMS PA pressure sensor and managed by a single cardiovascular team using a previously published hemodynamic treatment algorithm. Each participant received a simplified treatment guide (sliding scale) prescribing how to adjust diuretic doses based on their own PA pressure readings, which were relayed to them daily through the Epic MyChart patient portal. Protocol-mandated laboratory testing followed each diuretic adjustment. The study measured safety (hospitalizations, urgent visits, kidney injury, syncope, electrolyte disturbances) and effectiveness (heart failure hospitalizations, average PA diastolic pressure, and how often the care team needed to intervene) over 90 days, with quality of life assessed by the Minnesota Heart Failure Questionnaire. A separate retrospective chart-review cohort of 31 CardioMEMS patients served as a comparison group.
详细描述
Non-randomized, prospective, single-center feasibility study. Participants who complete the study function as their own comparative controls. Planned screening of 30 patients with planned enrollment of 15; actual enrollment was 21. Per protocol addendum, a retrospective chart-review cohort (N=31 patients with a CardioMEMS device and 6 months of data from implant date, not included in the prospective arm) serves as a control/baseline comparison using data already in the medical record; no additional visits, questionnaires, or blood draws were required for that cohort. Adverse events were pre-defined in the protocol as: hypokalemia, hospitalization, syncope, urgent clinic/ER visit, and acute kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(prospective arm participants must meet ALL of 1-7; retrospective cohort inclusion limited to criterion 1):
- •Currently implanted with and actively transmitting remote pulmonary artery pressures using the CardioMEMS HF system and exclusively managed by the Froedtert Menomonee Falls Cardiovascular Team according to previously published hemodynamic treatment algorithm.
- •Provision of signed and dated informed consent
- •Stated willingness to comply with study procedure and mandates and remain available for the duration of the study period of 90 days.
- •Males and females; Ages 40-90
- •Documented diagnosis of heart failure (regardless of ejection fraction) with volume related symptoms managed with a loop diuretic.
- •Willingness to participate in a shared-management strategy
- •Access to necessary resources for participating in a technology-based intervention (i.e., Epic MyChart via computer, smartphone, or tablet with internet access)
排除标准
- •(any ONE excludes):
- •Allergy/intolerance to loop or thiazide diuretics.
- •Oliguria/anuria either acute or chronic.
- •Chronic kidney disease Stage IV, V, or undergoing renal replacement therapy.
- •Transplant organ recipient
- •Chronic immunosuppressant therapy
- •Idiopathic fluid collections (for example ascites, pulmonary or pericardial effusions)
- •Currently undergoing chemotherapy for malignancy or having received chemotherapeutic treatment in the past 12 months.
- •Hospice plan of care or prior designation of hospice plan of care within 12 months.
- •Advanced heart failure designation with or without durable mechanical circulatory support.
- •Technically or medically illiterate precluding use of Epic MyChart application.
- •Blister packaged medications
- •Resident of group/assisted living facility.
- •Either partially or completely dependent on social/family support for IADLs/ADLs
结局指标
主要结局
Hospitalization(s)
时间窗: 90 days
All cause and adjudicated heart failure specific hospitalization(s)
Urgent office visit(s)
时间窗: 90 days
Unscheduled visits to outpatient office, urgent care, or emergency department for heart failure symptom or management of consequence directly related to heart failure management.
Adverse event(s)
时间窗: 90 days
Events include syncope, acute kidney injury/failure, or significant electrolyte derangements requiring intravenous corrective therapy that were directly due to heart failure treatment(s).
Diastolic pulmonary artery pressure average
时间窗: 90 days
Cohort wide average PA diastolic pressure during the first two weeks and last two weeks of study period.
Provider/treatment team intervention(s)
时间窗: 90 days
Either by request from patient or necessity deemed by provider/treatment team, intervention that was not explicitly outlined in the patient specific protocol/therapy titration adjustment plan.
次要结局
- Time in optimal PA pressure range (TIR-PAP)(90 days)
- Diuretic burst frequency(90 days)
研究者
Marc Atzenhoefer
Attending, Cardiovascular Medicine
Medical College of Wisconsin