A Study to Estimate the Week to Week and Month to Month Fluctuations of a Heart Hormone (NT-proBNP) in Patients on Dialysis

Not Applicable

Completed

• Conditions: Cardiomyopathy; Renal Dialysis; Renal and Urogenital - Kidney disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12611000657921
• Lead Sponsor: Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified