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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL171893-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Heart Association | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Arm | Patients followed before and after transplant | ||
| Waitlist Control Arm | Patients followed before transplant while on the waitlist |
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| Measure | Description | Time Frame |
|---|---|---|
| Stress Myocardial Blood Flow (MBF) | Myocardial blood flow with hyperemic stress measured on PET myocardial perfusion imaging | 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) | Ratio of stress and rest myocardial blood flow assessed by PET | 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, %) | Left ventricular global longitudinal strain measured on echocardiography | 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') | E/E' measured by echocardiography | 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 | IL-6 levels measured via proteomics assays | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | LVEF by echocardiography | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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People with advanced kidney disease who are candidates for renal transplant will be included in the RESTORE study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel M Huck, MD, MPH | Contact | 8573074000 | dhuck@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
All longitudinal human subjects data described in outcomes measures will be shared in a deidentified form. Both summarized data and individual will be shared via ClinicalTrials.gov and BioLINCC. Cardiovascular imaging data including PET and echocardiography will be shared as calculated parameters after expert interpretation from the raw images. The raw images will not be shared in a data depository, due to very large file-size, and the need for specialized software and expertise to interpret the imaging data. However, raw images may be available in a deidentified form upon appropriate and relevant request with an appropriate data transfer agreement. The protocol, sample informed consent, sample surveys, and data dictionaries will be shared on a data repository.
Start Date: June 30, 2030 End Date: Indefinite ClinicalTrials.gov and BioLINCC will make decisions about how long to preserve the data, but no deposited data has been deleted up to now.
All summarized and completely deidentified data on ClinicalTrials.gov will be publicly accessible without restriction. Data and metadata on the data repository BioLINCC will be controlled by standard processes at BioLINCC, including requirement for being a registered user on BioLINCC, the submission of an online request form, IRB approval, a research material distribution agreement, and approval by the NHLBI Data Repository Program Officer
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Blood (Plasma, Serum, Peripheral blood mononuclear cell PMBCs) and Urine
| Vascular Endothelial Growth Factor A (VEGF-A) | VEGF-A measured by proteomic assay | 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 | ANGPT1 levels measured by proteomic assay | 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 | ANGPT2 levels measured by proteomics | 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 |
| 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 | High-sensitivity troponin by blood assay | 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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