Effect of allopurinol on arterial stiffness indices in patients with chronic heart failure
| ISRCTN | ISRCTN58980230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58980230 |
| Secondary identifying numbers | 201065 |
- Submission date
- 01/02/2011
- Registration date
- 01/03/2011
- Last edited
- 19/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Manal Alem
Scientific
Scientific
Department of Pharmacology
College of Medicine
Imam Abdulrahman bin Faisal University
PO Box 34872
Dammam
31478
Saudi Arabia
 ORCID ID |
0000-0001-8447-792X |
|---|---|
| malem@alfaisal.edu |
Study information
| Study design | Prospective randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effect of allopurinol on arterial stiffness indices in patients with chronic heart failure: a prospective randomised double-blind placebo-controlled study |
| Study objectives | 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(s) | The University of Dammam (now Imam Abdulrahman bin Faisal University) Ethics Committee, 26/05/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 08/01/2011 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/01/2011 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Imam Abdulrahman bin Faisal University
Dammam
31478
Saudi Arabia
31478
Saudi Arabia
Sponsor information
Imam Abdulrahman bin Faisal University
University/education
University/education
PO Box 1982
Dammam
31441
Saudi Arabia
| dsr@ud.edu.sa | |
| Website | http://www.iau.edu.sa/ |
"ROR" |
https://ror.org/038cy8j79 |
Funders
Funder type
University/education
Imam Abdulrahman bin Faisal University
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/06/2018 | Yes | No |
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.
