None listed
Conditions
Brief summary
The aim of the study is to establish the magnitude of variation in serial measurements of a cardiac hormone (NT-proBNP) that can be attributed to homeostatic fluctuations around a set-point (biological variation). Such information will be used to inform monitoring guidelines as to the magnitude of fluctuations that are not associated with adverse outcomes at the individual level and that can be safely ignored. The study also intends to establish the analytic performance of the most commonly used NT-proBNP assay (Roche Elecsys 2010) in the dialysis population.
Interventions
Within person biological variation, between person variation, and within- and between run analytic variation of a cardiac hormone (NT-proBNP) measured at weekly intervals for four weeks followed by monthly intervals for four months
Sponsors
Princess Alexandra Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In-centre haemo- or peritoneal dialysis patients established on a single dialysis modality for at least 90-days Stable dialysis prescription for at least one month Aged 18-years or older Able to provide informed consent Echocardiogram within 12-months of enrollment
Exclusion criteria
Living renal transplantation planned within 5-months of enrolment. Home haemodialysis Patients on peritoneal dialysis not receiving continuous therapy (e.g. NIPD). Permanent pacemaker and/or implantable cardiac defibrillator. Joint replacements, orthopaedic pins, mechanical heart valves and amputations. Any of the following events / conditions in the month prior to screening: Admission to hospital for any cause. Change in dry body weight target of > 1kg. Unscheduled haemodialysis for treatment of hypertension, dyspnoea or congestive cardiac failure. Change in dialysis prescription. Initiation or dose alteration of angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta-blocker, or aldosterone receptor antagonist. If has ischaemic heart disease – change in severity of angina – increased frequency and/or occurrence with lesser degrees of exertion and/or alteration in dose of anti-anginal agent(s). If has arrhythmia – change in dose of anti-arrhythmic agent or initiation of new anti-arrhythmic agent. Systemic infection. Congenital heart disease (excluding haemodynamically insignificant patent foramen ovale). Documented severe left ventricular systolic dysfunction defined as an ejection fraction less than 30% by Simpson’s rule. Severe aortic stenosis or regurgitation. Severe mitral stenosis or regurgitation. Severe pulmonary hypertension (RVSP > [60 mmHg > RA]) due to any cause. ST or non-ST segment myocardial infarction (defined as a combination of serial elevation in Troponin T and any one of new ST/T wave changes on ECG and/or symptoms of cardiac ischaemia) in the 6-months prior to screening. Cardiac surgery and/or coronary angioplasty in the 6-months prior to screening. Pulmonary embolism in the preceding 6-months. Advanced malignancy. Pregnancy. Current immunosuppressive pharmacotherapy for any indication.
Outcome results
None listed