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

NCT ID: NCT07222683

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Kidney Transplant Coronary Microvascular Dysfunction (CMD) Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transplant Arm

Patients followed before and after transplant

No interventions assigned to this group

Waitlist Control Arm

Patients followed before transplant while on the waitlist

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

American Heart Association (AHA)

UNKNOWN

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daniel Michael Huck, MD, MPH

Clinical Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel M Huck, MD, MPH

Role: CONTACT

8573074000

Facility Contacts

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Daniel M Huck, MD, MPH

Role: primary

8573074000

Other Identifiers

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K23HL171893-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P002317

Identifier Type: -

Identifier Source: org_study_id

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