Contact information
Type
Scientific
Primary contact
Dr Manal Alem
ORCID ID
http://orcid.org/0000-0001-8447-792X
Contact details
Department of Pharmacology
College of Medicine
Imam Abdulrahman bin Faisal University
PO Box 34872
Dammam
31478
Saudi Arabia
-
malem@alfaisal.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
201065
Study information
Scientific title
Effect of allopurinol on arterial stiffness indices in patients with chronic heart failure: a prospective randomised double-blind placebo-controlled study
Acronym
Study hypothesis
Allopurinol add-on therapy (300 mg daily dose for 3 months) in clinically-stable patients with chronic heart failure will result in reduction of arterial stiffness parameters, augmentation index (AIx) and aortic pulse wave velocity (PWV) (carotid-femoral).
Ethics approval
The University of Dammam (now Imam Abdulrahman bin Faisal University) Ethics Committee, 26/05/2010
Study design
Prospective randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic heart failure
Intervention
Every patient will have a total of 4 visits.
Preliminary visit:
For explaining the nature of the trial, get the consent forms signed and for demonstration of SphygmoCardiography technique and to get the patient acclimatised to it via taking some arterial stiffness readings that will not be included in the study statistics. Blood samples will be taken for baseline screening; haematological and biochemical screening. Baseline echocardiogram and ECG will also be done.
Visit 0:
For arterial stiffness parameters measurements and baseline stress test, after which the patient will be randomised by a pharmacist to any of the treatment arms.
Safety visit:
For checking how the patient is doing with the study medication (1 month after). Blood samples will be taken for complete blood count, renal and liver function tests.
Visit 1 (3 months post-randomisation):
For arterial stiffness parameters measurements and a repeat stress test.
Medications:
Allopurinol: Apo-Allopurinol 300 mg tablet once daily (APOTEX Pharmaceutical, Canada). Duration: 90 days.
Placebo: manufactured locally at Al Jazeera Pharmaceutical, Riyadh, Saudi Arabia, 1 tablet once daily. Duration: 90 days.
Intervention type
Drug
Phase
Not Applicable
Drug names
Allopurinol
Primary outcome measure
Arterial stiffness indices:
1. Pulse wave velocity (PWV)
2. Augmentation index
Assessed at visit 0 (baseline) and after 90 days post-randomisation (visit 1)
Secondary outcome measures
Exercise capacity, assessed at visit 0 (baseline) and after 90 days post-randomisation (visit 1)
Overall trial start date
08/01/2011
Overall trial end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years, either sex
2. Chronic heart failure patients with functional class II - III (according to New York Heart Association [NYHA])
3. Clinical stabilisation of cardiac condition and medications for at least 3 months prior to involvement
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Serum creatinine greater than 2 mg/dl or creatinine clearance of less than 60 ml/min
2. Recent admission to hospital within the last 3 months due to decompensated heart failure or new ischaemic event
3. Uncontrolled blood pressure (BP greater than 160/100 mmHg)
4. Concomitant antioxidant vitamins
5. Known hypersensitivity reaction to allopurinol
Recruitment start date
08/01/2011
Recruitment end date
01/12/2012
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Imam Abdulrahman bin Faisal University
Dammam
31478
Saudi Arabia
Sponsor information
Organisation
Imam Abdulrahman bin Faisal University
Sponsor details
PO Box 1982
Dammam
31441
Saudi Arabia
-
dsr@ud.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Imam Abdulrahman bin Faisal University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The data sets generated during and/or analyzed during the current study are/will be available upon request from Dr Manal Alem (malem@alfaisla.edu). No analyses will allowed on raw data unless agreed and approved by local ethics committee.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29899669