The Interrogation of the Cardiomyopathy of Chronic Kidney Disease With advancEd caRdiac Imaging

NCT03704701 | Terminated

• 2 other identifiers: GN17RE700243630
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with kidney failure have a much higher risk of heart disease compared to people of the same age without kidney failure. The reason for this is not fully understood. In this project we will use Cardiac MRI (CMR), which is a very detailed scan of the heart and blood vessels, to try to better understand the cardiovascular changes that occur in kidney failure. We will perform CMR scans in 30 patients before and after dialysis (a treatment for patients with kidney failure) to see whether dialysis changes the heart muscle. The same patients will also undergo another type of heart scan, called a CT scan. This will allow us to compare the pictures from the 2 different types of scan to help us better understand any damage to the heart muscle that is present. Finally, we will test a new way to measure hardening of blood vessels on CMR. These three studies will help us to better understand the heart and blood vessel changes that happen in kidney failure. This research will also be useful for patients without kidney failure. We hope to be able to use it in the future to see which new treatments might be able to reduce the risk of heart disease in patients with kidney failure.

Conditions

Chronic Kidney Diseases; Cardiomyopathies; Cardiovascular Diseases; Cardiac Disease

Outcome Measures

Primary Outcomes (3)

• Part 1A: Myocardial native T1 in response to changing fluid status

  Change in myocardial native T1 mapping (MOLLI) on cardiac MRI at visit 2, compared to visit 1, following removal of excess fluid by ultrafiltration.

  24 hours

• Part 1B: Measurement of myocardial extracellular volume by CT (ECV-CT)

  Comparison between myocardial extracellular volume on contrast-enhanced CT and myocardial native T1 times measured on cardiac MRI.

  Baseline

• Part 1C: Vascular calcification on MRI

  Comparison between Cardiac MRI and CT to detect the presence or absence of vascular calcification within the thoracic aorta at the level of the right pulmonary artery (PA).

  Baseline

Interventions

Cardiac MRI and contrast-enhanced cardiac CT DIAGNOSTIC_TEST

Cardiac MRI Contrast-enhanced cardiac CT

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients established on regular hospital-based haemodialysis, with evidence of recurrent fluid overload requiring fluid removal by ultrafiltration on dialysis.

You may qualify if:

• Age 40-100 years at time of recruitment.
• Established on regular day-time, hospital-based haemodialysis for \>6 months.
• History of recurrent fluid overload, defined as a mean of \>1.5 litres fluid removal per dialysis session from an average of 3 consecutive sessions.
• No previous clinical diagnosis of heart failure, or if previous clinical diagnosis of heart failure then must have preserved left ventricular function (ejection fraction \>50% or reported as 'normal' or (similar)) on most recent transthoracic echo.
• Ability to comply with study procedures, including ability to lie flat for up to 1 hour.
• Ability to give informed consent.

You may not qualify if:

• Standard contra-indications to MRI, including the presence of certain metallic objects in the body (e.g. non-MRI compatible cardiac devices, previous cranial surgery with ferromagnetic clips, metal fragments in eye, etc.) and severe claustrophobia.
• Known allergy to iodinated radiological contrast.
• Asthma (unless previous CT with contrast administration within the past 12 months without adverse effect).
• Pregnancy, lactation or women of child-bearing potential not willing to use highly effective contraception for the duration of the study.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for routine clinical parameters and novel biomarkers of cardiovascular disease and fibrosis.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiomyopathies; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alastair J Rankin, MBChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: October 10, 2018
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

GB (1)