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

ConditionsChronic Kidney DiseaseKidney TransplantCoronary Microvascular Dysfunction (CMD)Inflammation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Transplant Arm
Group B: Waitlist Control Arm

Trial outcomes

Primary outcomes

1

Stress Myocardial Blood Flow (MBF)

Myocardial blood flow with hyperemic stress measured on PET myocardial perfusion imaging

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
2

Myocardial Flow Reserve (MFR)

Ratio of stress and rest myocardial blood flow assessed by PET

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
3

Left ventricular global longitudinal strain (GLS, %)

Left ventricular global longitudinal strain measured on echocardiography

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
4

Left ventricular mitral inflow velocity to mitral annular early diastolic relaxation velocity ration (E/E')

E/E' measured by echocardiography

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

Secondary outcomes

1

Left ventricular ejection fraction (LVEF)

LVEF by echocardiography

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
2

High sensitivity c-reactive protein (hs-CRP)

hs-CRP measured by blood assay

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
3

High-sensitivity Troponin

High-sensitivity troponin by blood assay

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

American Heart Association

Collaborator

Source ClinicalTrials.gov
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