search
Back to results

Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.

Primary Purpose

Hypertension, Renal

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bisoprolol Fumarate 5-10 mg
Amlodipine 5-10 mg
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Renal

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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, Office based BP >140/90 and/or on antihypertensive medication.

Exclusion Criteria:

  • 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

Sites / Locations

  • El Mowassat University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Amlodipine

Bisoprolol

Arm Description

Hypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen.

Hypertensive patients on dialysis receiving Bisoprolol 5-10 mg tablet daily alone or as part of antihypertensive regimen.

Outcomes

Primary Outcome Measures

Change in Left Ventricular Mass Index

Secondary Outcome Measures

Change in ADMA Blood level

Full Information

First Posted
September 8, 2019
Last Updated
February 16, 2021
Sponsor
Alexandria University
Collaborators
Damanhour University
search

1. Study Identification

Unique Protocol Identification Number
NCT04085562
Brief Title
Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
Official Title
Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
Collaborators
Damanhour University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amlodipine
Arm Type
Experimental
Arm Description
Hypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen.
Arm Title
Bisoprolol
Arm Type
Experimental
Arm Description
Hypertensive patients on dialysis receiving Bisoprolol 5-10 mg tablet daily alone or as part of antihypertensive regimen.
Intervention Type
Drug
Intervention Name(s)
Bisoprolol Fumarate 5-10 mg
Intervention Description
Bisoprolol as antihypertensive drug in patients on hemodialysis
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5-10 mg
Intervention Description
Amlodipine as antihypertensive drug in patients on hemodialysis
Primary Outcome Measure Information:
Title
Change in Left Ventricular Mass Index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in ADMA Blood level
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, Office based BP >140/90 and/or on antihypertensive medication. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Youssef, BSPharm
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noha El-khodary, Phd
Organizational Affiliation
Faculty of pharmacy, Damanhour University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maged Wasfy, Phd
Organizational Affiliation
Faculty of pharmacy, Damanhour University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hesham Elghonemy, Phd
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
El Mowassat University hospital
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data underlying results.
IPD Sharing Time Frame
Starting 6 months after publication.
IPD Sharing Access Criteria
Controlled access to data. Requests are made to the PI. Requests are reviewed and answered by the PI. Data will be provided through E-mail.
Citations:
PubMed Identifier
34941131
Citation
Youssef AM, Elghoneimy HA, Helmy MW, Abdelazeem AM, El-Khodary NM. Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial. Medicine (Baltimore). 2021 Dec 23;100(51):e28322. doi: 10.1097/MD.0000000000028322.
Results Reference
derived

Learn more about this trial

Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.

We'll reach out to this number within 24 hrs