NCT06521801

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress32%
Aug 2024Jun 2030

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

July 22, 2024

Last Update Submit

January 5, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Mortality

    30 days and 1 year

  • Re-admission rates

    30 days and 1 year

  • Major Adverse Cardiac Events

    30 days and 1 year

  • Major Adverse Kidney Events

    30 days and 1 year

Study Arms (1)

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.

Other: Observation

Interventions

Observation

Patients with Renal Disease or Cardiology Disease

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include all patients admitted to or reviewed at The Royal London Hospital (RLH) who have renal disease. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients will include those who have end stage renal disease, seen in the low clearance clinic, are on dialysis, are on the renal transplant list and who are post renal transplant. Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicCardio-Renal SyndromeMyocardial InfarctionStroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart FailureHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Krishnaraj Rathod, MBBS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations