Clinical trial NCT04085562: Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
Official title: Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension, Renal
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Damanhour University
First posted: 2019-09-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Left Ventricular Mass Index
timeFrame: 6 months
Secondary outcomes:
measure: Change in ADMA Blood level
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: El Mowassat University hospital
Study officials:
affiliation: Alexandria University
name: Ahmed M Youssef, BSPharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of pharmacy, Damanhour University
name: Noha El-khodary, Phd
role: STUDY_DIRECTOR
affiliation: Faculty of pharmacy, Damanhour University
name: Maged Wasfy, Phd
role: STUDY_DIRECTOR
affiliation: University of Alexandria
name: Hesham Elghonemy, Phd
role: STUDY_DIRECTOR
References:
citation: 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.