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

Overview

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.

Primary outcome measures

• Stress Myocardial Blood Flow (MBF) [Time frame: 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) [Time frame: 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, %) [Time frame: 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') [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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]

Secondary outcome measures (3)

• Left ventricular ejection fraction (LVEF) [Time frame: 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) [Time frame: 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 [Time frame: 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT07222683 · 2022P002317 · K23HL171893-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗