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Clinical Trials/NCT06521801
NCT06521801
Recruiting
Not Applicable

Barts Health Cardio-Renal Registry

Queen Mary University of London1 site in 1 country60,000 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Observation
Conditions
End Stage Renal Disease
Sponsor
Queen Mary University of London
Enrollment
60000
Locations
1
Primary Endpoint
Re-admission rates
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR <60 mL/min/1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the "treatment risk paradox," has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population.

This data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
June 1, 2030
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Nephrology team.
  • Inclusion Criteria:
  • Both male and female patients ≥16 years of age will be included
  • All patients will be reviewed by the Nephrology team a the RLH with renal disease.

Exclusion Criteria

  • 1\. Patients \<16 years will not be included in this study.

Arms & Interventions

Patients with Renal Disease or Cardiology Disease

This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients with renal disease and cardiac disease.

Intervention: Observation

Outcomes

Primary Outcomes

Re-admission rates

Time Frame: 30 days and 1 year

Major Adverse Cardiac Events

Time Frame: 30 days and 1 year

Major Adverse Kidney Events

Time Frame: 30 days and 1 year

Mortality

Time Frame: 30 days and 1 year

Study Sites (1)

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