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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-02-01

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.

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Detailed Description

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Conditions

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Hypertension, Renal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amlodipine

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

Group Type EXPERIMENTAL

Amlodipine 5-10 mg

Intervention Type DRUG

Amlodipine as antihypertensive drug in patients on hemodialysis

Bisoprolol

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

Group Type EXPERIMENTAL

Bisoprolol Fumarate 5-10 mg

Intervention Type DRUG

Bisoprolol as antihypertensive drug in patients on hemodialysis

Interventions

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Bisoprolol Fumarate 5-10 mg

Bisoprolol as antihypertensive drug in patients on hemodialysis

Intervention Type DRUG

Amlodipine 5-10 mg

Amlodipine as antihypertensive drug in patients on hemodialysis

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No