Hypertension, RenalPhase 4NCT04085562
Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
A Phase 4 study testing Bisoprolol Fumarate 5-10 mg and Amlodipine 5-10 mg in people with Hypertension, Renal, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Renal
- What is being tested?
- Bisoprolol Fumarate 5-10 mg and Amlodipine 5-10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of malignancy.
- History of significant valvular heart disease.
- Chronic congestive heart failure.
- History of coronary artery disease.
- Ongoing atrial fibrillation.
- Known drug abuse.
Show all 9Show fewer
- Known contraindication to Bisoprolol or Amlodipine.
- History of MI
- History of Stroke
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Bisoprolol Fumarate 5-10 mg, Amlodipine 5-10 mg
- Medical subject headings
- Hypertension, Renal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisoprolol Fumarate 5-10 mgDrug
Bisoprolol as antihypertensive drug in patients on hemodialysis
Amlodipine 5-10 mgDrug
Amlodipine as antihypertensive drug in patients on hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine | Experimental | Hypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen. Receives: 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. Receives: Drug: Bisoprolol Fumarate 5-10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Mass Index
Measured: 6 months
Secondary outcomes (1)
Change in ADMA Blood level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Sep 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, RenalStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Damanhour University
- Responsible party
- Principal investigator, Ahmed Youssef, Alexandria University
- Investigators
- Ahmed M Youssef, BSPharm, Principal investigator, Alexandria UniversityNoha El-khodary, Phd, Study director, Faculty of pharmacy, Damanhour UniversityMaged Wasfy, Phd, Study director, Faculty of pharmacy, Damanhour UniversityHesham Elghonemy, Phd, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085562
- Sponsor's protocol ID
- 0201243
- Status last verified
- Feb 2021
- First submitted
- 8 Sep 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data underlying results.
Publications
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.
PubMed 34941131
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
- ClinicalTrials.gov ID
- NCT04085562
- Acronym / sponsor ID
- 0201243
- Conditions
- Hypertension, Renal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Damanhour University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine | Experimental | Drug: Amlodipine 5-10 mgHypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen. |
| Bisoprolol | Experimental | Drug: Bisoprolol Fumarate 5-10 mgHypertensive patients on dialysis receiving Bisoprolol 5-10 mg tablet daily alone or as part of antihypertensive regimen. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- History of malignancy.
- History of significant valvular heart disease.
- Chronic congestive heart failure.
- History of coronary artery disease.
- Ongoing atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisoprolol Fumarate 5-10 mgBisoprolol as antihypertensive drug in patients on hemodialysis | Drug | Bisoprolol |
| Amlodipine 5-10 mgAmlodipine as antihypertensive drug in patients on hemodialysis | Drug | Amlodipine |
Primary outcome
Change in Left Ventricular Mass Index
Time frame: 6 months
1 secondary outcome
Change in ADMA Blood level
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 34941131Youssef 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.
- Individual participant dataSharing planned: Yes. Data underlying results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Youssef, BSPharm principal investigator
Alexandria University
Noha El-khodary, Phd study director
Faculty of pharmacy, Damanhour University
Maged Wasfy, Phd study director
Faculty of pharmacy, Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol Fumarate 5-10 mg and Amlodipine 5-10 mg in people with Hypertension, Renal, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Mass Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.