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

Hypertension, Renal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085562
• Other study ID #: 0201243
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Renal
• Kidney Failure, Chronic

Intervention

Drug:
• Bisoprolol Fumarate 5-10 mg
Bisoprolol as antihypertensive drug in patients on hemodialysis
• Amlodipine 5-10 mg
Amlodipine as antihypertensive drug in patients on hemodialysis

Locations

Country	Name	City	State
Egypt	El Mowassat University hospital	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left Ventricular Mass Index		6 months
Secondary	Change in ADMA Blood level		6 months