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Completed

NCT Number: NCT03649646

FimasaRtan-basEd BP Targets After Drug SwitcHing

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University Hospital

Suwon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)

    Time frame: Week 12 after the treatment regimen change

    Percentage of patients who attain the target blood pressure (BP) (<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change

Secondary outcomes

  1. Percentage of Patients With Controlled BP According to 2018 KSH Guideline

    Time frame: Week 12 after the treatment regimen change

    Percentage of patients who attain the target BP specified in 2018 hypertension clinical practice guidelines* suggested by Korean Society of Hypertension at Week 12 after the treatment regimen change.

    *2018 hypertension clinical practice guidelines : Target BP <140(SBP)/90(DBP) mmHg.

    For patients meeting any of the conditions listed below, each corresponding criterion will be applied.

    • Patients with cardiovascular disease :<130/80 mmHg
    • Patients with diabetes : <140/85 mmHg
    • Patients with diabetes accompanying cardiovascular disease :<130/80 mmHg
    • Patients with chronic kidney disease accompanying albuminuria: <130/80 mmHg

  2. Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline

    Time frame: Week 12 after the treatment regimen change

    Percentage of patients who attain the target BP(<130(SBP)/80(DBP)mmHg) specified in 2017 clinical practice guidelines for hypertension suggested by American College of Cardiology(ACC)/American Heart Association(AHA) at Week 12 after the treatment regimen change

  3. Prcentage of Patients With Controlled BP According to Investigator's Target BP

    Time frame: Week 12 after the treatment regimen change

    Percentage of patients who attain the investigator's target BP* at Week 12 after the treatment regimen change.

    *Investigator's target BP: Target BP for each patient set by the investigator at baseline.

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target BP Attainment in Patients Whose Antihypertensive Regimens Are Changed to ARB-based Therapy

Acronym: FRESH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2018
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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