Chronic Kidney DiseaseRESTORENCT07222683
The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease
An observational study of Chronic Kidney Disease and Kidney Transplant, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Kidney Transplant, Coronary Microvascular Dysfunction (CMD)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with advanced kidney disease who are candidates for renal transplant will be included in the RESTORE study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Daniel M Huck, MD, MPH, 8573074000, dhuck@bwh.harvard.edu
About this study
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.
Read more
The study will test whether:
- Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD.
- Kidney transplant improves heart blood flow and function.
- 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.
- Conditions
- Chronic Kidney Disease, Kidney Transplant, Coronary Microvascular Dysfunction (CMD), Inflammation
- Keywords
- chronic kidney disease, coronary microvascular dysfunction, kidney transplant, cardiovascular inflammation, dysregulated angiogenesis, coronary artery disease
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transplant Arm | Patients followed before and after transplant | |
| Waitlist Control Arm | Patients followed before transplant while on the waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Myocardial Blood Flow (MBF)
Myocardial blood flow with hyperemic stress measured on PET myocardial perfusion imaging
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
VEGF-A measured by proteomic assay
Measured: 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
Measured: 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
Measured: 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 outcomes (3)
Left ventricular ejection fraction (LVEF)
LVEF by echocardiography
Measured: 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)
hs-CRP measured by blood assay
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start10 Mar 2023
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
- Responsible party
- Principal investigator, Daniel Michael Huck, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222683
- Sponsor's protocol ID
- 2022P002317
- Other IDs
- K23HL171893-01A1
- Acronym
- RESTORE
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07222683
- Acronym / sponsor ID
- RESTORE / 2022P002317
- Conditions
- Chronic Kidney Disease, Kidney Transplant, Coronary Microvascular Dysfunction (CMD), Inflammation
- Keywords
- chronic kidney disease, coronary microvascular dysfunction, kidney transplant, cardiovascular inflammation, dysregulated angiogenesis, coronary artery disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD.
- Kidney transplant improves heart blood flow and function.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplant Arm | – | –Patients followed before and after transplant |
| Waitlist Control Arm | – | –Patients followed before transplant while on the waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with advanced kidney disease who are candidates for renal transplant will be included in the RESTORE study.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Kidney Transplant, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Huck, MD, MPH (8573074000, dhuck@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.