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

NCT04085562 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-02-17

No results posted yet for this study

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.

Conditions

  • Hypertension, Renal

Interventions

DRUG

Bisoprolol Fumarate 5-10 mg

Bisoprolol as antihypertensive drug in patients on hemodialysis

DRUG

Amlodipine 5-10 mg

Amlodipine as antihypertensive drug in patients on hemodialysis

Sponsors & Collaborators

  • Damanhour University

    collaborator OTHER

  • Alexandria University

    lead OTHER

Principal Investigators

  • Ahmed M Youssef, BSPharm · Alexandria University

  • Noha El-khodary, Phd · Faculty of pharmacy, Damanhour University

  • Maged Wasfy, Phd · Faculty of pharmacy, Damanhour University

  • Hesham Elghonemy, Phd · University of Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085562 on ClinicalTrials.gov