HypertensionNCT05328310
Effect of Different Antihypertensive Drugs on Central Blood Pressure
A study testing Nebivolol in people with Hypertension, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Trial name) The differential effects of antihypertensive drugs on central blood pressure: comparison between beta-blocker(BB) and angiotensin receptor blocker ARB) Objectives) To evaluate the effect of BB, which has vasodilatory effects, on CBP by comparison between ARB, one of the most widely used class of… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2019to Mar 2026
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients with newly diagnosed hypertension: SBP ≥140mmHg or DBP ≥90 mmHg
- For patients with prior diagnosis of hypertension: SBP ≥140mmHg or DBP ≥90 mmHg after a two-week washout period of previous antihypertensive medications.
- Patients who wrote the informed consent: The subject should be able to receive informations of treatment, risks, effects and other therapeutic modalities regarding different antihypertensive agents at least verbally, and investigators should be provided written informed consent from a subject or a legally recognized representative prior to giving any treatment related to the study.
Who cannot join
- Patients with contraindications or hypersensitive/allergic reactions to any class of antihypertensive agents.
- Severe hypertension patients: SBP ≥200mmHg or DBP ≥110 mmHg at any visit during the study.
- Chronic kidney disease (creatinine >1.5mg/dL)
- Chronic obstructive pulmonary disease
- Chronic heart failrue (LVEF ≤35%)
- Patients who are pregnant or plan on becoming pregnant during the duration of the study, both male and female sex
- Patients who are illiterate, have psychiatric illnesses or who do not agree to be enrolled in the study.
- Other patients who are deemed unfit for the study as assessed by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Differential Effects of Antihypertensive Drugs on Central Blood Pressure: Comparison Between Beta-blocker and ARB
Trial name) The differential effects of antihypertensive drugs on central blood pressure: comparison between beta-blocker(BB) and angiotensin receptor blocker ARB)
Objectives) To evaluate the effect of BB, which has vasodilatory effects, on CBP by comparison between ARB, one of the most widely used class of antihypertensives.
Read more
Study design) A multicenter, prospective, randomized, controlled, open-label clinical trial for hypertension patients.
Patient enrollment) 110 patients will be enrolled at 2 centers in South Korea.
Patient follow-up) Patients will go through an initial washout period of two weeks prior to randomization. After pre-medication baseline visit and randomization, clinical follow-up will occur at 4, 8, 12 weeks after initial administration of randomized drug. The follow-up visits are office visits.
Primary endpoint) Reduction in CBP at 12 weeks.
Secondary endpoints) Clinical events including adverse reactions to the drugs.
Read the detailed description
- Study background Different antihypertensive agents induce varied response in terms of CBP, even if peripheral BP-lowering effects are similar. In ASCOT-CAFE study, the atenolol±thiazide group and the amlodipine±perindopril group had similar efficacy in lowering peripheral BP, but CBP was significantly higher in the atenolol±thiazide group. This, amongst other studies, provided grounds for BBs being exempted from first-line therapy for hypertension. A possible explanation for this suboptimal performace of BB in lowering CBP is that in the atenolol±thiazide group, the lowered heart rate and subsequently an increase in systolic time promotes the augmentation of systolic pressure waves by the pressure wave reflections. Second, the comparatively high vasoconstricting effects of atenolol±thiazide group may result in a more proximal formation of pressure waves. Recently, third-generation BBs such as nebivolol have been developed, with additional vasodilatory effects which distinguishes them from previous BBs, and less accentuated heart rate-slowing effects. However, the effect of these new-generation of BBs on CBP is yet to be elucidated.
- Study objectives The primary objective of this study is to evaluate the clinical efficacy of nebivolol, a BB, in lowering the CBP compared to telmisartan, an ARB.
- Medical devices and therapeutic agents The medical devices and therapeutic agents to be used in this study are the treatment modalities that have been proven to be beneficial in the treatment of hypertensive patients without clear contraindications.
- Expected effects of the research The clinical benefits of lowering CBP as well as peripherally measured BP have been previously described. Currently, the use of BBs in hypertensive patients is limited to those with clear indications such as concomitant atrial fibrillation or heart failure, due to its inferiority in lowering CBP compared to other antihypertensive agents. For those with coincident indications for BBs, or those with contraindications to other classes of antihypertensives, having a secure alternative first-line drug would be beneficial. This study is expected to give evidence for, or against, the use of BBs in hypertensive patients in terms of lowering the CBP in addition to PBP.
- Clinical trial monitoring Monitor personnel designated by the investigator to obtain quality test data will review the clinical trial data at appropriate intervals to ensure accuracy, completeness, and compliance with the protocol. The monitoring personnel can investigate all documents and essential records held by clinical investigators or clinical trial laboratories, including the medical records (office, clinic, and hospital) of the subjects participating in the clinical trial. Clinical investigators and researchers should allow access to these records to the monitoring personnel. The monitoring plan will be conducted three times in total, at the time of registering the number of subjects corresponding to 50% or more of the total enrollment number, when the completed research subject reaches 70% or more, and immediately before the end of the study.
- Conditions
- Hypertension
- Being tested
- Nebivolol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Treatment of nebivolol instead of telmisartan; the drug administration is mutually exclusive for the two arms.
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Active comparator | Within enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, telmisartan is given as the primary antihypertensive agent. Receives: Drug: Nebivolol |
| Nebivolol | Experimental | Within enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, nebivolol is given as the primary antihypertensive agent. Receives: Drug: Nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central blood pressure
Differential changes in CBP by nebivolol and telmisartan
Measured: Initial admission date and follow-up visits at 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start6 Jan 2019
- Primary completionDec 2022 (estimated)
- Study completionMar 2026 (estimated)
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 HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheol Woong Yu, Korea University Anam Hospital
- Investigators
- Cheol Woong Yu, M.D. Ph.D, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328310
- Sponsor's protocol ID
- ATD-CBP
- Status last verified
- Apr 2022
- First submitted
- 8 Feb 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim S, Kook H, Yu CW, Kim JH, Cha JJ, Joo HJ, Na JO, Choi CU, Lim SY, Park JH, Hong SJ, Lim DS. Differential Effects of Antihypertensive Drugs on Central Blood Pressure: A Randomized Comparison Between Nebivolol and Telmisartan. Am J Hypertens. 2026 Feb 1;39(2):303-311. doi: 10.1093/ajh/hpaf098.
PubMed 40490940
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Effects of Antihypertensive Drugs on Central Blood Pressure: Comparison Between Beta-blocker and ARB
- ClinicalTrials.gov ID
- NCT05328310
- Acronym / sponsor ID
- ATD-CBP
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Apr 2022 (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.
Trial name) The differential effects of antihypertensive drugs on central blood pressure: comparison between beta-blocker(BB) and angiotensin receptor blocker ARB)
Objectives) To evaluate the effect of BB, which has vasodilatory effects, on CBP by comparison between ARB, one of the most widely used class of antihypertensives.
Study design) A multicenter, prospective, randomized, controlled, open-label clinical trial for hypertension patients.
Patient enrollment) 110 patients will be enrolled at 2 centers in South Korea.
Patient follow-up) Patients will go through an initial washout period of two weeks prior to randomization. After pre-medication baseline visit and randomization, clinical follow-up will occur at 4, 8, 12 weeks after initial administration of randomized drug. The follow-up visits are office visits.
Primary endpoint) Reduction in CBP at 12 weeks.
Secondary endpoints) Clinical events including adverse reactions to the drugs.
Detailed description
- Study background Different antihypertensive agents induce varied response in terms of CBP, even if peripheral BP-lowering effects are similar. In ASCOT-CAFE study, the atenolol±thiazide group and the amlodipine±perindopril group had similar efficacy in lowering peripheral BP, but CBP was significantly higher in the atenolol±thiazide group. This, amongst other studies, provided grounds for BBs being exempted from first-line therapy for hypertension. A possible explanation for this suboptimal performace of BB in lowering CBP is that in the atenolol±thiazide group, the lowered heart rate and subsequently an increase in systolic time promotes the augmentation of systolic pressure waves by the pressure wave reflections. Second, the comparatively high vasoconstricting effects of atenolol±thiazide group may result in a more proximal formation of pressure waves. Recently, third-generation BBs such as nebivolol have been developed, with additional vasodilatory effects which distinguishes them from previous BBs, and less accentuated heart rate-slowing effects. However, the effect of these new-generation of BBs on CBP is yet to be elucidated.
- Study objectives The primary objective of this study is to evaluate the clinical efficacy of nebivolol, a BB, in lowering the CBP compared to telmisartan, an ARB.
- Medical devices and therapeutic agents The medical devices and therapeutic agents to be used in this study are the treatment modalities that have been proven to be beneficial in the treatment of hypertensive patients without clear contraindications.
- Expected effects of the research The clinical benefits of lowering CBP as well as peripherally measured BP have been previously described. Currently, the use of BBs in hypertensive patients is limited to those with clear indications such as concomitant atrial fibrillation or heart failure, due to its inferiority in lowering CBP compared to other antihypertensive agents. For those with coincident indications for BBs, or those with contraindications to other classes of antihypertensives, having a secure alternative first-line drug would be beneficial. This study is expected to give evidence for, or against, the use of BBs in hypertensive patients in terms of lowering the CBP in addition to PBP.
- Clinical trial monitoring Monitor personnel designated by the investigator to obtain quality test data will review the clinical trial data at appropriate intervals to ensure accuracy, completeness, and compliance with the protocol. The monitoring personnel can investigate all documents and essential records held by clinical investigators or clinical trial laboratories, including the medical records (office, clinic, and hospital) of the subjects participating in the clinical trial. Clinical investigators and researchers should allow access to these records to the monitoring personnel. The monitoring plan will be conducted three times in total, at the time of registering the number of subjects corresponding to 50% or more of the total enrollment number, when the completed research subject reaches 70% or more, and immediately before the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Active comparator | Drug: NebivololWithin enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, telmisartan is given as the primary antihypertensive agent. |
| Nebivolol | Experimental | Drug: NebivololWithin enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, nebivolol is given as the primary antihypertensive agent. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For patients with newly diagnosed hypertension: SBP ≥140mmHg or DBP ≥90 mmHg
- For patients with prior diagnosis of hypertension: SBP ≥140mmHg or DBP ≥90 mmHg after a two-week washout period of previous antihypertensive medications.
- Patients who wrote the informed consent: The subject should be able to receive informations of treatment, risks, effects and other therapeutic modalities regarding different antihypertensive agents at least verbally, and investigators should be provided written informed consent from a subject or a legally recognized representative prior to giving any treatment related to the study.
Key exclusion criteria (8 listed)
- Patients with contraindications or hypersensitive/allergic reactions to any class of antihypertensive agents.
- Severe hypertension patients: SBP ≥200mmHg or DBP ≥110 mmHg at any visit during the study.
- Chronic kidney disease (creatinine >1.5mg/dL)
- Chronic obstructive pulmonary disease
- Chronic heart failrue (LVEF ≤35%)
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 |
|---|---|---|
| NebivololTreatment of nebivolol instead of telmisartan; the drug administration is mutually exclusive for the two arms. | Drug | Nebivolol, Telmisartan |
Primary outcome
Central blood pressure
Time frame: Initial admission date and follow-up visits at 4, 8, 12 weeks
Differential changes in CBP by nebivolol and telmisartan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 40490940Lim S, Kook H, Yu CW, Kim JH, Cha JJ, Joo HJ, Na JO, Choi CU, Lim SY, Park JH, Hong SJ, Lim DS. Differential Effects of Antihypertensive Drugs on Central Blood Pressure: A Randomized Comparison Between Nebivolol and Telmisartan. Am J Hypertens. 2026 Feb 1;39(2):303-311. doi: 10.1093/ajh/hpaf098.
- Individual participant dataSharing planned: No
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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.
Cheol Woong Yu, M.D. Ph.D principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebivolol in people with Hypertension, run by Korea University Anam Hospital at 1 site in South Korea.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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 South Korea. 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.
Are results available for this study?
Results are not available in the source record.
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?
Central blood pressure (time frame: Initial admission date and follow-up visits at 4, 8, 12 weeks). 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 NCT05328310, 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 14 Apr 2022.