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

February 16, 2021 updated by: Ahmed Youssef, Alexandria University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • El Mowassat University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlodipine
Hypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen.
Drug: Amlodipine 5-10 mg
Amlodipine as antihypertensive drug in patients on hemodialysis
Experimental: Bisoprolol
Hypertensive patients on dialysis receiving Bisoprolol 5-10 mg tablet daily alone or as part of antihypertensive regimen.
Drug: Bisoprolol Fumarate 5-10 mg
Bisoprolol as antihypertensive drug in patients on hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Left Ventricular Mass Index
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ADMA Blood level
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Collaborators

Damanhour University

Investigators

  • Principal Investigator: Ahmed M Youssef, BSPharm, Alexandria University
  • Study Director: Noha El-khodary, Phd, faculty of pharmacy, Damanhour University
  • Study Director: Maged Wasfy, Phd, faculty of pharmacy, Damanhour University
  • Study Director: Hesham Elghonemy, Phd, University of Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

September 8, 2019

First Submitted That Met QC Criteria

September 8, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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