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

October 28, 2025 updated by: Daniel Michael Huck, MD, MPH, Brigham and Women's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with advanced kidney disease who are candidates for renal transplant will be included in the RESTORE study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transplant Arm
Patients followed before and after transplant
Waitlist Control Arm
Patients followed before transplant while on the waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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, %)
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association (AHA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

October 27, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Estimated)

October 30, 2025

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P002317
  • K23HL171893-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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