NCT05012722Completed
Arterial Stiffness in Heart Failure and Chronic Kidney Disease
A Comparison of Arterial Stiffness in Patients With Stable Heart Failure and Stable Chronic Kidney Disease Against Decompensated Heart Failure and Acute Kidney Injury
Source: ClinicalTrials.gov · Last updated 18 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 119 (actual)
- First submitted
- 2 Aug 2021
- Start date
- 30 Jan 2022
- Primary completion date
- 13 Dec 2023
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT05012722
What you commit to
- Study type: Observational
- Participants enrolled: 119
- From 30 Jan 2022 to the primary completion date, 13 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- \-
Who the study is looking for
- 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
- \-
Age in the registry: 60 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Coventry and Warwickshire Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.