FimasaRtan-basEd BP Targets After Drug SwitcHing (FRESH)

Boryung

Status: Completed

Conditions: Essential Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT03649646

BR-FMS-OS-404

Details and patient eligibility

About

The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.

Full description

This study will be performed in patients with blood pressure (BP) uncontrolled by existing antihypertensive drugs (including ARB) among hypertensive patients visiting outpatient clinic of medical institutions in Korea. The study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. Follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.

Enrollment: 4,542 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study

• Male or female adults ≥ 19 years who are diagnosed with essential hypertension

• Receiving outpatient treatment at the time of study enrollment

• Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens decided and scheduled to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)

  • Definition of uncontrolled hypertension: Target BP (SBP <140 mmHg and DBP <90 mmHg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer

Exclusion criteria

• Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
• Patients with suspected or confirmed secondary hypertension
• Pregnant or breast-feeding women
• Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
• Patients who are determined inappropriate for participating in the study by investigators for other reasons

Trial design

4,542 participants in 1 patient group

Patients

Description:

Patients with hypertension uncontrolled by antihypertensive drug