The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease
- Conditions
- Chronic Kidney DiseaseKidney TransplantCoronary Microvascular Dysfunction (CMD)Inflammation
- Registration Number
- NCT07222683
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stress Myocardial Blood Flow (MBF) 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) 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, %) 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') 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 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) 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 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 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
- Secondary Outcome Measures
Name Time Method 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 LVEF by echocardiography
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 hs-CRP measured by blood assay
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 High-sensitivity troponin by blood assay
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital🇺🇸Boston, Massachusetts, United StatesDaniel M Huck, MD, MPHContact8573074000dhuck@bwh.harvard.edu