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Arterial Stiffness in Heart Failure and Chronic Kidney Disease

NCT05012722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2024-06-18

No results posted yet for this study

Summary

This observational study is assessing the effects that arterial stiffness may have on patients with heart failure (HF) and chronic kidney disease (CKD). Arterial stiffness will be measured by assessing pulse wave velocity (PWV). Carotid- Femoral PWV is the gold standard in measuring arterial stiffness non- invasively. Many studies have shown increasing PWV is a predictor of cardiovascular events, but the significance of increasing PWV as a surrogate marker for the potential worsening (decompensation) of HF or CKD has not been explored.

This study aims to investigate patients with HF and CKD by assessing PWV while in a decompensated state and again when in a stable condition after 4 weeks of discharge to investigate a link between decompensation and rise of arterial stiffness.

The research team aim to recruit 120 patients in this study with 40 patients in each of the 3 groups- heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and acute kidney injury (AKI). All AKI patients would have had known CKD (stages 3a, 3b or 4).

The study participants will be initially recruited in hospital while admitted in an acute state and tests including bloods, ECG, echocardiography and PWV will be performed. The tests (excluding echocardiography) will be repeated 4 weeks after discharge. There is no intervention in this study.

The study seeks to improve the understanding of the role of the vasculature in the development of acute HF in the two common types- HFrEF and HFpEF. As CKD is a common comorbidity in heart failure patients we felt that a study of the behaviour of arterial stiffness in this cohort will add to this understanding. If arterial stiffness is found to be an important component of the HF syndrome therapeutic interest could be focused at managing arterial stiffness with novel therapy.

Conditions

  • Arterial Stiffness

Interventions

DIAGNOSTIC_TEST

Sphygmocor CVMS (Atocr Medical, Sydney Australia) PWV measurement

All patients included in this study will have a pulse wave velocity measurement measured using SphygmoCor cardiovascular management system (CVMS) (Atocr Medical, Sydney Australia) which is a tonometry-based device used to noninvasively obtain vital cardiovascular data.

Sponsors & Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

    lead OTHER

Principal Investigators

  • Prithwish Banerjee, MD,FRCP,FESC · Professor of Cardiology and Consultant Cardiologist (Chief Investigator)

  • Mithilesh Joshi, MBChB · Cardiology Research Fellow (Sub Investigator)

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-30
Primary Completion
2023-12-13
Completion
2023-12-13
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012722 on ClinicalTrials.gov