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

Phase 4

Completed

• Conditions: Hypertension, Renal
• Interventions: Drug: Bisoprolol Fumarate 5-10 mg; Drug: Amlodipine 5-10 mg

• Registration Number: NCT04085562
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-08
• Study First Posted: 2019-09-11
• Status Verified: 2021-02
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular Mass Index	6 months

Secondary Outcome Measures

Name	Time	Method
Change in ADMA Blood level	6 months

Trial Locations

Locations (1)

El Mowassat University hospital; 🇪🇬 Alexandria, Egypt