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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Renal

Intervention / Treatment
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* Drug: Bisoprolol Fumarate 5-10 mg
* Drug: Amlodipine 5-10 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Left Ventricular Mass Index |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADMA Blood level |  | 6 months |