Plain English Summary
Background and study aims
Dialysis is a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly. It often involves diverting blood to a machine to be cleaned. Normally, the kidneys filter the blood, removing harmful waste products and excess fluid and turning these into urine to be passed out of the body.
Studies have shown that dialysis patients can develop heart problems due to changes in nervous system activity.
The objective of the present study was to determine whether treatment with carvedilol can improve the symptoms of heart problems in patients on dialysis.
Who can participate?
Patients aged 18 years or above, with chronic kidney disease (CKD), having been on regular hemodialysis for more than 6 months.
What does the study involve?
Each patient was evaluated over a 14-day period. Hemodialysis was performed by medical staff who were unaware of the aim of the study. Patients and staff were both blinded to the additional treatment being administered: placebo on days 0 through 7; and carvedilol on days 8 through 14.
What are the possible benefits and risks of participating?
The benefit is better control of hypertension. The main risk is hypotension regarding the use of carvedilol.
Where is the study run from?
Mario Covas Hospital (Brazil)
When is the study starting and how long is it expected to run for?
October 2004 to August 2005
Who is funding the study?
The Brazilian National Council for Scientific and Technological Development (Brazil)
Who is the main contact?
Dr Joao Isuk Suh
Dr Joao Suh
Rua da Fonte 51
Effect of carvedilol on norepinephrine levels in hemodialysis patients: a prospective double-blind placebo-controlled clinical trial
The objective of this unprecedented study was to determine whether the use of carvedilol correlates with norepinephrine levels in hemodialysis patients
Approved 01/10/2004, ABC Medical School Research Ethics Committee (Lauro Gomes ave, 2000, Santo Andre, Sao Paulo, Brazil, 09060870; +55 1149935400; no email provided), ref 087/2004
Prospective interventional non-randomized placebo-controlled trial
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Cardiovascular disease in hemodialysis patients
This was a prospective study involving a cohort of stable patients recruited from eligible patients who were undergoing hemodialysis at the study centre hemodialysis clinic three times a week during the period of study
Each patient was evaluated over a 14-day period. Hemodialysis was performed by medical staff who were unaware of the aim of the study. Patients and staff were both blinded to the additional treatment being administered: placebo on days 0 through 7; and carvedilol on days 8 through 14. The carvedilol was given in increasing doses, from a minimum of 3.123 mg (twice a day) on day 8 to a maximum of 9.375 mg (twice a day) on day 14. Noninvasive (Holter) monitoring was performed on day 0 and on day 14. Plasma levels of norepinephrine were determined before and after hemodialysis on day 0 and day 14. Before and after hemodialysis on days 0, 7, and 14, patients completed a symptom questionnaire.
Primary outcome measure
Mean plasma norepinephrine level measured by High Performance Liquid Chromatography (HPLC) at 0 and 14 days
Secondary outcome measures
Number of ventricular arrhythmias registered by Holter monitoring at 0 and 14 days
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. 18 years or older
2. Having chronic kidney disease (CKD)
3. Having been on regular hemodialysis for more than 6 months
4. Having a hemoglobin level >10 mg/dl
5. Having a Kt/V >1.2 in more than three consecutive measures
6. Patients gave written informed consent
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Active liver disease
2. Any other decompensated disease
3. Previously used beta-blockers
4. Active infection
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Mario Covas Hospital
Henrique Calderazzo street 321 Santo Andre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
National Council for Scientific and Technological Development, CNPq
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
2008 results published in thesis https://teses.usp.br/teses/disponiveis/5/5159/tde-05082008-135611/publico/joaoisuksuh.pdf
IPD sharing statement:
All data, comments, informed consent model, and statistical analysis are available to the public permanently at the weblink above in the form of a monograph, or are available from the corresponding author on reasonable request.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)