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

NCT04085562 | Completed Phase 4 DMC

• 1 other identifier: 0201243
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Renal

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular Mass Index

  6 months

Secondary Outcomes (1)

• Change in ADMA Blood level

  6 months

Study Arms (2)

Amlodipine

EXPERIMENTAL

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

Drug: Amlodipine 5-10 mg

Bisoprolol

EXPERIMENTAL

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

Drug: Bisoprolol Fumarate 5-10 mg

Interventions

Bisoprolol Fumarate 5-10 mg DRUG

Bisoprolol as antihypertensive drug in patients on hemodialysis

Bisoprolol

Amlodipine 5-10 mg DRUG

Amlodipine as antihypertensive drug in patients on hemodialysis

Amlodipine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead
• Damanhour University: collaborator

Study Sites (1)

El Mowassat University hospital

Alexandria, Egypt

Location

Related Publications (1)

• Youssef AM, Elghoneimy HA, Helmy MW, Abdelazeem AM, El-Khodary NM. Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial. Medicine (Baltimore). 2021 Dec 23;100(51):e28322. doi: 10.1097/MD.0000000000028322.

  PMID: 34941131 DERIVED

MeSH Terms

Conditions

Hypertension, Renal

Interventions

Bisoprolol; Amlodipine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed M Youssef, BSPharm

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Noha El-khodary, Phd

  Faculty of pharmacy, Damanhour University

  STUDY DIRECTOR

• Maged Wasfy, Phd

  Faculty of pharmacy, Damanhour University

  STUDY DIRECTOR

• Hesham Elghonemy, Phd

  University of Alexandria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 11, 2019
• Study Start: September 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Starting 6 months after publication.
• Access Criteria: * Controlled access to data. * Requests are made to the PI. * Requests are reviewed and answered by the PI. * Data will be provided through E-mail.

Locations

EG (1)