Hemodynamic Frontiers in Heart Failure Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 12
- 主要终点
- Potassium
研究概览
简要总结
The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.
详细描述
Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
- •Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).
排除标准
- •Patients less than 18 years of age.
- •Pregnant women at the scheduled time of PA pressure sensor implant.
- •Patients unable or unwilling to have continuity of care in the heart failure clinic.
结局指标
主要结局
Potassium
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.
Hemoglobin
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
B-type natriuretic peptide (BNP)
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
aminoterminal pro B-type natriuretic peptide (NT-proBNP)
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Change in hemodynamics
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.
Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 3 months, 6 months, 12 months, 24 months and 36 months post implant.
Changes in Echocardiogram (ECHO)
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available.
Medication changes
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies.
Sodium
时间窗: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.
次要结局
未报告次要终点