Topic: Cardiovascular disease
Conditions
Interventions
Blood sampling, ECG, 6MWT. In addition to blood sampling on each study visit, participants will have to fill in a Kansas city cardiomyopathy questionnaire and have an ECG. Some visits will require an
Sponsors
Portsmouth Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study arm - acute decompensated heart failure (ADHF) patients: 1. Patients admitted with acute decompensated heart failure (defined as symptoms and signs secondary to abnormal cardiac function with weight gain of more than 3 kg above target weight or requiring intravenous diuretics for >48 hours). 2. Patients should be able to give informed consent. Control arm - patients with stable heart failure: 1. There should be a prior diagnosis of CHF based on the presence of signs and symptoms of heart failure with objective evidence of a structural or functional abnormality of the heart at rest. 2. Patients should already be established on therapy, i.e. diuretics if required, ACE inhibitors/ARBs, beta blockers and aldosterone antagonists. 3. They should not have had a hospitalisation in the last 3 months. Control arm - healthy age-matched particpants: 1. There should be no known cardiac abnormality or history of anaemia or iron deficiency. 2. They should not have any chronic conditions requiring aspirin, beta blockers, ACE inhibitors, ARBs or aldosterone antagonist therapy in the last 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients less than 18 years of age 2. Patients who are part of any other ongoing research study 3. Hospitalisation for stable heart failure or age-matched control patient in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Prevalence of iron deficiency (absolute and functional) in acute decompensated heart failure 2. Change in iron status (transferrin saturation) at 4 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Is iron deficiency independently predicted by: 1.1. Haemoglobin level 1.2. Hepcidin level 1.3. Renal function using serum creatinine 1.4. Serum urate 1.5. Inflammatory markers (C-reactive protein (CRP), Interleukin [IL] -1, IL-6) 1.6. Biomarkers of heart failure (B-natriuretic peptide [BNP]) and renal function (N-gal) 1.7. Right heart pressures assessed on trans-thoracic echocardiogram 1.8. Fluid loss during inpatient stay (assessed from daily weight charts maintained during in-patient stay) 1.9. 6-Minute Walk Test (6MWT) performed as per American Thoracic Society guidelines 1.10. Quality of Life assessed by using The Kansas City Cardiomyopathy Questionnaire (KCCQ) 2. Compare prevalence of iron deficiency between patients in systolic heart failure (LVEF <45%) vs diastolic heart failure and atrial fibrillation vs sinus rhythm. 3. Using a multivariate model and logistic regression analysis, we will ascertain whether the changes in iron status (change in transferrin saturation) post discharge from hospital are independently related to: 3.1. Blood parameters (haemoglobin, hepcidin, renal function, urate, inflammatory markers [CRP, TNF- a, IL-1 and IL-6], biomarkers BNP, N-gal) 3.2. Right heart pressures assessed on trans-thoracic echocardiogram 3.3. Fluid loss during inpatient stay 3.4. 6-Minute Walk Test (6MWT) 3.5. QOL assessed by using The Kansas City Cardiomyopathy Questionnaire 3.6. Presence of systolic (LVEF <45%) or diastolic heart failure 4. We will additionally assess prognosis defined as outcomes at 1 year (death and hospitalisation) in: 4.1. ADHF patients with iron deficiency vs no iron deficiency 4.2. ADHF patients with iron | — |
Countries
United Kingdom
Outcome results
None listed