Clincosm LogoSign in Get a demo

Development of Diagnostic and Treatment Strategy for Resistant Hypertension

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03540992
Collaborator
(none)
780
Enrollment
1
Location
60.5
Anticipated Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a registry study to examine the clinical features, blood pressure control rate, and clinical prognosis of resistant hypertension in Koreans. This study will register patients with resistance hypertension in eight tertiary hospitals in Korea and follow up them for three years. The prognosis will be analysed according to etiologies, achieved blood pressure, and types of antihypertensive medication.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. Basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. Screening for renal artery stenosis and primary aldosteronism will be conducted. Office blood pressure will be taken every 3-6 months. Home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. The primary outcome is the newly developed MACE during the follow-up period. The secondary outcomes are newly developed target organ damage (LVH confirmed by echocardiography or EKG, carotid femoral PWV≥ 12m/s, microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). The follow-up period is 3 years.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    780 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of Diagnostic and Treatment Strategy for Resistant Hypertension
    Actual Study Start Date :
    Feb 14, 2018
    Anticipated Primary Completion Date :
    Feb 28, 2023
    Anticipated Study Completion Date :
    Feb 28, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiac events [3 years]

      Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails

    Secondary Outcome Measures

    1. Progression of CKD [3 years]

      Start dialysis or doubling of serum creatinine

    2. Target organ damages [3 years]

      Target organ damage: LVH confirmed by echocardiography or EKG; carotid femoral PWV≥ 12m/s; microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)

    3. Target blood pressure achievement [3 years]

      Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 20 years and older

    2. Office SBP>130 mmHg or office DBP >90 mmHg with 3 antihypertensive medications of different classes

    3. Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics

    Exclusion Criteria:

    1. desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)

    2. women with pregnancy or on nursing

    3. within the first three months after transplantation

    4. acute renal allograft rejection

    5. within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke

    6. systolic heart failure (LVEF ≤40%)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology Severance Cardiovascular Hospital Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT03540992
    Other Study ID Numbers:
    • 4-2017-1222
    First Posted:
    May 30, 2018
    Last Update Posted:
    May 30, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of May 30, 2018