Effects of a Reduction in Renal Function on Cardiovascular Structure and Function
CRIB-DONOR II
1 other identifier
observational
95
1 country
1
Brief Summary
Chronic kidney disease (CKD) is present in 1 in 7 of the population and confers a high risk of cardiovascular disease. The pathophysiology of cardiovascular disease in CKD is poorly understood because CKD is always accompanied by confounding factors including the underlying disease process (e.g. diabetes mellitus, systemic vasculitis) and the consequences of CKD including hypertension, anaemia and inflammation. Nephrectomy in kidney donors causes a 30% reduction in renal function providing an ideal study population to measure prospectively the effects of reduced kidney function on the cardiovascular system. The CRIB-Donor study (ClinicalTrials.gov Identifier:NCT01028703) demonstrated adverse effects on cardiovascular structure and function at 12 months compared to controls including an increase in left ventricular mass. This proposal will measure the changes in cardiovascular structure and function, cardiovascular age and biochemical changes at 5 years providing information on the long term effects of reduced renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedStudy Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedOctober 5, 2020
October 1, 2018
2.8 years
November 22, 2016
October 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular mass and interstitial fibrosis
Measured by CMR (part 1 of study).
3 years
Secondary Outcomes (4)
Aortic compliance
3 years
Cardiovascular age
3 years
Oxidative stress, inflammation and collagen turnover
3 years
Blood pressure
3 years
Study Arms (2)
Donors
Patients who donated a kidney and took part in the original CRIB-DONOR study.
Controls
Healthy subjects who took part in the original CRIB-DONOR study.
Interventions
Eligibility Criteria
Living donors and healthy controls
You may qualify if:
- All patients who took part in the original CRIB-Donor study.
You may not qualify if:
- Pregnant women
- Patients will have previously met nationally set criteria for living donation which excludes those with:
- Diabetes mellitus Atrial fibrillation Left ventricular dysfunction (ejection fraction \<40% on transthoracic echocardiography) History of cardiovascular or pulmonary disease Evidence of hypertensive end-organ damage.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH, United Kingdom
Biospecimen
Serum, plasma, acellular urine and DNA (for telomere length).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor John Townend, MbChB
University Hospital Birmingham NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 25, 2016
Study Start
May 23, 2017
Primary Completion
March 20, 2020
Study Completion
July 31, 2020
Last Updated
October 5, 2020
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share