The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease

Обзор

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: 1. Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD. 2. Kidney transplant improves heart blood flow and function. 3. 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.

Первичные конечные точки

• Stress Myocardial Blood Flow (MBF) [Срок оценки: 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 Flow Reserve (MFR) [Срок оценки: 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 (GLS, %) [Срок оценки: 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 mitral inflow velocity to mitral annular early diastolic relaxation velocity ration (E/E') [Срок оценки: 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]
• Interleukin-6 (IL-6) levels [Срок оценки: 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]
• Vascular Endothelial Growth Factor A (VEGF-A) [Срок оценки: 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]
• Angiopoeitin-1 (ANGPT1) Levels [Срок оценки: 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]
• Angiopoeitin-2 (ANGPT2) Levels [Срок оценки: 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]

Вторичные конечные точки (3)

• Left ventricular ejection fraction (LVEF) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT07222683 · 2022P002317 · K23HL171893-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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