Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT07222683

Conditions

Chronic Kidney Disease

Kidney Transplant

Coronary Microvascular Dysfunction (CMD)

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Chronic Kidney Disease

Kidney Transplant

Coronary Microvascular Dysfunction (CMD)

Inflammation

Study ID

NCT07222683

Start date

Mar 10, 2023

Status verified date

Oct, 2025

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Transplant Arm

Patients followed before and after transplant

Waitlist Control Arm

Patients followed before transplant while on the waitlist

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 ]
  • 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 ]
  • 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 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Daniel M Huck, MD, MPH

8573074000dhuck@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Daniel M Huck, MD, MPH

8573074000dhuck@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • chronic kidney disease
  • coronary microvascular dysfunction
  • kidney transplant
  • cardiovascular inflammation
  • dysregulated angiogenesis
  • coronary artery disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-10-30.