Effect of Different Antihypertensive Drugs on Central Blood Pressure

NCT05328310 | Active Not Recruiting DMC

• 1 other identifier: ATD-CBP
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Central blood pressure

  Differential changes in CBP by nebivolol and telmisartan

  Initial admission date and follow-up visits at 4, 8, 12 weeks

Study Arms (2)

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.

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.

Drug: Nebivolol

Interventions

Nebivolol DRUG

Treatment of nebivolol instead of telmisartan; the drug administration is mutually exclusive for the two arms.

Nebivolol; Telmisartan

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cheol Woong Yu, M.D. Ph.D

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 14, 2022
• Study Start: January 6, 2019
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2026
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)