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

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ClinicalTrials.gov Identifier: NCT04085562
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Damanhour University
Information provided by (Responsible Party):
Ahmed Youssef, Alexandria University

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.

Condition or disease Intervention/treatment Phase
Hypertension, Renal Drug: Bisoprolol Fumarate 5-10 mg Drug: Amlodipine 5-10 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020


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




Primary Outcome Measures :
  1. Change in Left Ventricular Mass Index [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in ADMA Blood level [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085562


Contacts
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Contact: Ahmed M Youssef, BSPharm 201067676798 ahmed_youssef@alexu.edu.eg

Locations
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Egypt
El Mowassat University hospital Recruiting
Alexandria, Egypt
Contact: Ahmed M Youssef, BSPharm    201067676798    ahmed_youssef@alexu.edu.eg   
Principal Investigator: Ahmed M Youssef, BSPharm         
Sponsors and Collaborators
Alexandria University
Damanhour University
Investigators
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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

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Responsible Party: Ahmed Youssef, Teaching assistant, Alexandria University
ClinicalTrials.gov Identifier: NCT04085562     History of Changes
Other Study ID Numbers: 0201243
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Starting 6 months after publication.
Access Criteria:
  • Controlled access to data.
  • Requests are made to the PI.
  • Requests are reviewed and answers by the PI.
  • Data will be provided through E-mail.

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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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Kidney Failure, Chronic
Hypertension, Renal
Hypertension
Vascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Amlodipine
Bisoprolol
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents