The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stress Myocardial Blood Flow (MBF)
研究概览
简要总结
People with chronic kidney disease (CKD) often experience faster aging of the heart and blood vessels, which raises the risk of heart problems beyond traditional factors like high blood pressure or cholesterol. One early sign is reduced blood flow in the tiny vessels that supply the heart, measured by a positron emission tomography (PET) scan using a marker called myocardial flow reserve (MFR). In CKD, ongoing inflammation and abnormal blood vessel growth can damage these small vessels, leading to heart stiffness and weaker heart function.
A kidney transplant offers a unique chance to study how better kidney function and reduced inflammation affect heart health. The observational RESTORE study ("Impact of Renal Transplant on Coronary Microvascular Function in Patients with Advanced CKD") will measure heart blood flow and function before and after transplant.
The study will test whether:
- Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD.
- Kidney transplant improves heart blood flow and function.
- Lower inflammation after transplant leads to better heart health.
By understanding how kidney disease and inflammation affect the heart-and how transplant may reverse these effects-this research could help guide future treatments to better protect heart health in patients with CKD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Renal transplant candidate on the waitlist
- •Age greater or equal to 45 years, or if 18-44 years of age on dialysis for 5 years or more
排除标准
- •Left ventricular ejection fraction (LVEF) < 40%
- •History of coronary artery bypass grafting (CABG)
- •History of heart transplant
- •Patients who undergo revascularization as a result of pre-transplant cardiac PET
结局指标
主要结局
Stress Myocardial Blood Flow (MBF)
时间窗: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
Myocardial blood flow with hyperemic stress measured on PET myocardial perfusion imaging
Myocardial Flow Reserve (MFR)
时间窗: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
Ratio of stress and rest myocardial blood flow assessed by PET
Left ventricular global longitudinal strain (GLS, %)
时间窗: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
Left ventricular global longitudinal strain measured on echocardiography
Left ventricular mitral inflow velocity to mitral annular early diastolic relaxation velocity ration (E/E')
时间窗: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
E/E' measured by echocardiography
Interleukin-6 (IL-6) levels
时间窗: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
IL-6 levels measured via proteomics assays
Vascular Endothelial Growth Factor A (VEGF-A)
时间窗: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
VEGF-A measured by proteomic assay
Angiopoeitin-1 (ANGPT1) Levels
时间窗: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
ANGPT1 levels measured by proteomic assay
Angiopoeitin-2 (ANGPT2) Levels
时间窗: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist
ANGPT2 levels measured by proteomics
次要结局
- Left ventricular ejection fraction (LVEF)(1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist)
- High sensitivity c-reactive protein (hs-CRP)(1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist)
- High-sensitivity Troponin(1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist)
研究者
Daniel Michael Huck, MD, MPH
Clinical Investigator
Brigham and Women's Hospital