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

Mass General Brigham

Status: Enrolling

Conditions: Chronic Kidney Disease; Inflammation; Coronary Microvascular Dysfunction (CMD); Kidney Transplant

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07222683

2022P002317

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

Details and patient eligibility

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). 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Transplant Arm

Description:

Patients followed before and after transplant

Waitlist Control Arm

Description:

Patients followed before transplant while on the waitlist