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| Name | Class |
|---|---|
| Damanhour University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine | Experimental | Hypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen. |
|
| Bisoprolol | Experimental | Hypertensive patients on dialysis receiving Bisoprolol 5-10 mg tablet daily alone or as part of antihypertensive regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol Fumarate 5-10 mg | Drug | Bisoprolol as antihypertensive drug in patients on hemodialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Mass Index | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ADMA Blood level | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Mowassat University hospital | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34941131 | Derived | 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. |
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Data underlying results.
Starting 6 months after publication.
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| ID | Term |
|---|---|
| D006977 | Hypertension, Renal |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Amlodipine 5-10 mg | Drug | Amlodipine as antihypertensive drug in patients on hemodialysis |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |