Condition category
Circulatory System
Date applied
27/08/2020
Date assigned
02/09/2020
Last edited
01/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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
joaoisuh@uol.com.br

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joao Suh

ORCID ID

Contact details

Apto 81
Rua da Fonte 51
Santo Andre
09040270
Brazil
+55 11983819976
joaoisuh@uol.com.br

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

151 Effect

Study information

Scientific title

Effect of carvedilol on norepinephrine levels in hemodialysis patients: a prospective double-blind placebo-controlled clinical trial

Acronym

EFFECT

Study hypothesis

The objective of this unprecedented study was to determine whether the use of carvedilol correlates with norepinephrine levels in hemodialysis patients

Ethics approval

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

Study design

Prospective interventional non-randomized placebo-controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular disease in hemodialysis patients

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Carvedilol

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

01/10/2004

Overall trial end date

01/08/2005

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

26

Total final enrolment

26

Participant exclusion criteria

1. Active liver disease
2. Any other decompensated disease
3. Previously used beta-blockers
4. Active infection
5. Hospitalized

Recruitment start date

01/12/2004

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Brazil

Trial participating centre

Mario Covas Hospital
Henrique Calderazzo street 321 Santo Andre
Sao Paulo
09190615
Brazil

Sponsor information

Organisation

University of Sao Paulo

Sponsor details

Teodoro Sampaio Street 115
São Paulo
05405000
Brazil
+55 1130618203
angelica.belem@hc.fm.usp.br

Sponsor type

University/education

Website

http://www5.usp.br/en/

Funders

Funder type

Government

Funder name

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Alternative name(s)

National Council for Scientific and Technological Development, CNPq

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Brazil

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

01/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes