Condition category
Circulatory System
Date applied
01/02/2011
Date assigned
01/03/2011
Last edited
19/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.iau.edu.sa/

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

Publication citations

Additional files

Editorial Notes

19/06/2018: PubMed link added. 14/06/2018: IPD sharing statement added. 13/06/2018: Publication reference added, contact details updated. 30/05/2018: The ethics approval and trial centre fields have been updated to reflect that Imam Abdulrahman bin Faisal University is the new name for the University of Dammam.