Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05328310 |
| Other study ID # |
ATD-CBP |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2019 |
| Est. completion date |
March 2026 |
Study information
| Verified date |
April 2022 |
| Source |
Korea University Anam Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
Description:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
