NCT07222683 · Brigham and Women's Hospital
The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease
(RESTORE)
What this study is about
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).
View original scientific description
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 blood flow with hyperemic stress measured on PET myocardial perfusion imaging
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
Ratio of stress and rest myocardial blood flow assessed by PET
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 global longitudinal strain measured on echocardiography
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
E/E' measured by echocardiography
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
IL-6 levels measured via proteomics assays
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
VEGF-A measured by proteomic assay
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
ANGPT1 levels measured by proteomic assay
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
ANGPT2 levels measured by proteomics
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations