Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04085562
Enrollment
46
Registered
2019-09-11
Start date
2019-09-01
Completion date
2021-02-01
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Renal

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.

Interventions

DRUGBisoprolol Fumarate 5-10 mg

Bisoprolol as antihypertensive drug in patients on hemodialysis

DRUGAmlodipine 5-10 mg

Amlodipine as antihypertensive drug in patients on hemodialysis

Sponsors

Damanhour University
CollaboratorOTHER
Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Left Ventricular Mass Index6 months

Secondary

MeasureTime frame
Change in ADMA Blood level6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026