Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003218439 Date of Approval: 19/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cardio-oncology study
Official scientific title Detecting and treating subclinical anthracycline therapy related cardiac dysfunction in low income country
Brief summary describing the background and objectives of the trial To date, there is no contemporary data in Uganda to address the burden, pathogenesis, risk factors and treatment of subclinical anthracycline therapy ralated cardiac dysfunction (ATRCD). This knowledge gap has lead to lack of local guideline for monitoring and management of ATRCD. The objectives of this research are to describe the burden of subclinical ATRCD by applying international guideline on Uganda cancer patient and to evaluate the significance of treating subclinical ATRCD with carvedilol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SATRACD
Disease(s) or condition(s) being studied Anthracycline therapy related cardiac dysfunction,Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 19/04/2018
Actual trial start date
Anticipated date of last follow up 17/04/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by Redcap online sofeware Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Carvedilol highest tolerate dose, but not more than 50mg twice daily 6 months Carvediolol will be initiated from 3.125mg twice daily and titrated two weekly until the highest tolerate dose which is not more than 50mg twice daily. 25
Control Group No intervention No interbention 6 months No intervention 25 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age: 18 to 50 years Cancer patients who received anthracycline therapy and developed subclinical ATRCD during follow up Patient who is taking carvedilol Patient who has any of the conditions:HT,DM,CKD,CAD Patient who has low LVEF 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 05/02/2018 SCHOOL OF MEDICINE RESEARCH AND ETHICS COMMITTEE MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES
Ethics Committee Address
Street address City Postal code Country
College of Health Science, Makerere University, Mulago Hill Road Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevention of the worsening of GLS(global longitudinal strain) 6 months after randomization
Secondary Outcome Reduce the level of oxidative stress 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Uganda Heart Institute Mulago Hospital Complex,Mulago Hill Road Kampala 7051 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
NURTURE Makerere University, College of Health Science Kampala 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Cape Town Rondebosch 7701 Cape Town Private Bag X3 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr. Feriel Azibani Hatter Institute for Cardiovascular Research in Africa,4 Floor, Chris Barnard Building 2 Anzio Road, Observatory Cape Town Private Bag X3, 7925 South Africa
Prof. Karen Sliwa Hatter Institute for Cardiovascular Research in Africa,4 Floor, Chris Barnard Building 2 Anzio Road, Observatory Cape Town Private Bag X3, 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wan Zhu Zhang raniox@hotmail.com +256774431009 Mulago Hospital Complex, Molago Hill Raod
City Postal code Country Position/Affiliation
Kampala 7051 Uganda Hatter Institute for Cardio vesicular Research in Africa, Uganda Heart Institute
Role Name Email Phone Street address
Public Enquiries Karen Sliwa karen.sliwa-hahnle@uct.ac.za +27 21 021 406 6457 4th Floor, Chris Barnard Building
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Director, Hatter Institute for Cardiovascular Research in Africa,
Role Name Email Phone Street address
Scientific Enquiries Feriel Feriel feriel.azibani@uct.ac.za +27 21 021 406 6457 4th Floor, Chris Barnard Building
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Postdoctoral Fellow, Hatter Institute for Cardiovascular Research in Africa,
REPORTING
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