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.: PACTR201909547623017 Date of Approval: 16/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Amlodipine versus Bisoprolol on Hypertensive Patients with End-stage Renal Disease on Maintenance Hemodialysis.
Official scientific title Effect of Amlodipine versus Bisoprolol on Hypertensive Patients with End-stage Renal Disease on Maintenance Hemodialysis.
Brief summary describing the background and objectives of the trial Hypertension is highly prevalent in hemodialysis (HD) patients and leads to increased morbidity and mortality due to cardiovascular disease(CVD). Left ventricular hypertrophy (LVH) is both a manifestation of hypertension caused end-organ damage and an independent risk factor for CVD. Evidence shows that Beta-blockers, especially of low dialyzability decrease risk of CVD and mortality. Calcium channel blockers (CCBs) were also shown to effectively control BP in the volume expanded state and reduce cardiovascular disease risk. Asymmetric dimethyl arginine (ADMA) is a uremic toxin that decreases NO synthesis and is correlated to LVH, carotid intimal thickness (CIT), CVD, and mortality. Amlodipine is shown in one study to significantly reduce ADMA level in HD patients. The purpose of this study is to determine the effect of calcium channel blocker Amlodipine compared to Beta-blocker Bisoprolol on regression of LVH, reduction of ADMA plasma level and on BP control among hypertensive patients on HD.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date 01/02/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 46
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Amlodipine 5- 10 mg daily 6 month CCB for Blood pressure control for hypertensive patients on dialysis 30 Active-Treatment of Control Group
Experimental Group Bisoprolol 5-10 mg 6 months Beta-Blocker for blood pressure control in hypertensive patients on dialysis. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18-80. Male or female patients. On maintenance hemodialysis 3 times weekly for at least 3 months. Hypertensive as determined by predialytic BP > 140/ 90, post-dialytic > 130/80, home- measured BP >140/90 and/or on antihypertensive medication. History of malignancy. • History of significant valvular heart disease. • Chronic congestive heart failure. • History of coronary artery disease. • Ongoing atrial fibrillation. • Known drug abuse. • Known contraindication to Bisoprolol or Amlodipine. • History of MI • History of stroke 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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
Yes 17/06/2019 Alexandria Faculty of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria 21111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Between-group differences in change from baseline (CFB) to 6 months in LVMI. Baseline and after 6 months
Secondary Outcome Between-group differences in CFB to 6 months in ADMA serum blood level. Baseline and after 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Mouwasat University Hospital Fahmy Abdel Magid St. Off El Horreya Rd., El hadara, Alexandria Near To Faculty Of Engineering - Alexandria Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator Ahmed Youssef 18-Behreng st. Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Youssef 18-Behreng St. wahbour elmayah Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Hesham Elghonemy Alexandria Faculty of medicine. Alexandria Egypt
Dr Maged Wasfy Damanhour Faculty of Pharmacy Damanhour Egypt
Dr. Noha ElKhodary Damanhour Faculty of Pharmacy Damanhour Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Youssef ahmed_youssef@alexu.edu.eg 00201067676798 18- Behreng ST, Wahbour elmayah, Alexandria
City Postal code Country Position/Affiliation
Alexandria Egypt Teaching Assistant Faculty of pharmacy Alexandria University
Role Name Email Phone Street address
Public Enquiries Ahmed Youssef ahmed_youssef@alexu.edu.eg 201067676798 18- Behreng ST, Wahbour elmayah, Alexandria
City Postal code Country Position/Affiliation
Alexandria Egypt Teaching Assistant Faculty of pharmacy Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Youssef ahmed_youssef@alexu.edu.eg 201067676798 18- Behreng ST, Wahbour elmayah, Alexandria
City Postal code Country Position/Affiliation
Alexandria Egypt Teaching Assistant Faculty of pharmacy Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie results in a publication Informed Consent Form Starting 6 months after publication. - Controlled access to data. - Requests are made and reviewed by the PI. - Data will be shared with researchers for conduction of Meta-analysis and reviews. -Data will be provided through E-mail
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information