Arterial Stiffness in Heart Failure and Chronic Kidney Disease

NCT05012722 | Completed FDA Device

• 1 other identifier: MJ550021
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart Failure; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Pulse Wave Velocity (m/s)

  PWV is a measure of arterial stiffness which can be done non invasively at bedside using a device called SphygmoCor CVMS machine (Atcor Medical, Sydney, Australia

  12 months

Secondary Outcomes (3)

• Assess the relationship between NYHA heart failure class and PWV

  12 months

• Assess the relationship between CKD stage and PWV

  12 months

• Assess any correlation between non invasive blood pressure & PWV

  12 months

Study Arms (3)

Decompensated Heart Failure with reduced ejection fraction (HFrEF)

Pulse wave velocity to be measured during hospitalisation phase and repeated 4 weeks after when participant is in a stable state i.e stable (HFrEF)

Diagnostic Test: Sphygmocor CVMS (Atocr Medical, Sydney Australia) PWV measurement

Decompensated Heart Failure with Preserved ejection fraction (HFpEF)

Pulse wave velocity to be measured during hospitalisation phase and repeated 4 weeks after when participant is in a stable state i.e stable (HFpEF)

Diagnostic Test: Sphygmocor CVMS (Atocr Medical, Sydney Australia) PWV measurement

Acute Kidney Injury in patients with Chronic Kidney Disease stage 3a,3b or 4

Pulse wave velocity to be measured during hospitalisation phase and repeated 4 weeks after when participant is in a stable state i.e. stable Chronic Kidney Disease stage 3a, 3b and 4

Diagnostic Test: Sphygmocor CVMS (Atocr Medical, Sydney Australia) PWV measurement

Interventions

Sphygmocor CVMS (Atocr Medical, Sydney Australia) PWV measurement DIAGNOSTIC_TEST

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.

Also known as: No intervention

Acute Kidney Injury in patients with Chronic Kidney Disease stage 3a,3b or 4; Decompensated Heart Failure with Preserved ejection fraction (HFpEF); Decompensated Heart Failure with reduced ejection fraction (HFrEF)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will have either have decompensated heart failure or acute kidney injury in CKD stage 3a,3b or 4 during the hospitalisation phase

You may qualify if:

• Male or Female age ≥60 Known or documented diagnosis of Heart Failure ( Heart Failure with reduced ejection fraction HFrEF or Heart Failure with preserved ejection fraction HFpEF) on admission or prior to admission. HFrEF is defined as Left Ventricular ejection fraction (LVEF) of \<40%, HFpEF is defined as LVEF \>50% as in accordance with the classification by the European Society of Cardiology.
• Patients on optimal evidence based therapy for heart failure Known or documented diagnosis of Chronic Kidney Disease stage 3a, 3b or 4, for minimum period of ≥6 months

You may not qualify if:

• Severe Peripheral Vascular Disease Patients who have had a myocardial infarction or coronary artery bypass surgery within 6 months Severe Anaemia Hb 70g/dl Dementia or unable to consent lack mental capacity Bedbound/ Immobile patients Severe Liver Failure Severe Chronic Obstructive Pulmonary Disease Patients on LTOT (Long Term Oxygen Therapy) Renal transplant Previous or Current Renal Replacement Therapy (Peritoneal Dialysis or Haemodialysis) Sepsis

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospital Coventry and Warwickshire

Coventry, West Midlands, CV2 3DX, United Kingdom

Location

Related Publications (1)

• Joshi M, Tran P, Barber TM, Khweir L, Appunu K, Ayub W, Banerjee P. Arterial stiffness in acute decompensated heart failure and acute kidney injury: a prospective observational cohort study protocol in a tertiary hospital setting. BMJ Open. 2025 Jun 23;15(6):e097718. doi: 10.1136/bmjopen-2024-097718.

  PMID: 40550719 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests only

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; 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

• Prithwish Banerjee, MD,FRCP,FESC

  Professor of Cardiology and Consultant Cardiologist (Chief Investigator)

  STUDY CHAIR

• Mithilesh Joshi, MBChB

  Cardiology Research Fellow (Sub Investigator)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 19, 2021
• Study Start: January 30, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

GB (1)