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OpenTrials
Completed

NCT Number: NCT04085562

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

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

El Mowassat University hospital

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisoprolol Fumarate 5-10 mg

Drug

Bisoprolol as antihypertensive drug in patients on hemodialysis

Amlodipine 5-10 mg

Drug

Amlodipine as antihypertensive drug in patients on hemodialysis

Primary outcomes

  1. Change in Left Ventricular Mass Index

    Time frame: 6 months

Secondary outcomes

  1. Change in ADMA Blood level

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Damanhour University

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2019
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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