Development of Diagnostic and Treatment Strategy for Resi... | NCT03540992

Studies
Development of Diagnostic and Treatment Strategy for Resistant Hypertension

NCT03540992

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

May 30, 2018Actual

Enrollment

780Estimated

Phase

Not provided

Conditions

Resistant Hypertension

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2018Actual

Primary Completion Date

Feb 28, 2023Estimated

Completion Date

Feb 28, 2023Estimated

First Submitted Date

May 3, 2018

First Submission Date that Met QC Criteria

May 28, 2018

First Posted Date

May 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2018

Last Update Posted Date

May 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

780Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse cardiac events	Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails	3 years

Secondary Outcomes

Measure	Description	Time Frame
Progression of CKD	Start dialysis or doubling of serum creatinine	3 years
Target organ damages	Target organ damage: LVH confirmed by echocardiography or EKG; carotid femoral PWV≥ 12m/s; microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 years and older
Office SBP>130 mmHg or office DBP >90 mmHg with 3 antihypertensive medications of different classes
Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics

Exclusion Criteria:

desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)
women with pregnancy or on nursing
within the first three months after transplantation
acute renal allograft rejection
within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke
systolic heart failure (LVEF ≤40%)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A pateint diagnosed with resistant hypertension

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sungha Park, MD	Contact	82-2-2228-8455		shpark0530@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology Severance Cardiovascular Hospital	Recruiting	Seoul		03722	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39543419	Derived	Seo J, Lee CJ, Kim DH, Kim SY, Moon JY, Park JH, Son JW, Kim JY, Kim IC, Rhee MY, Lee JH, Lee HY, Chung JW, Ihm SH, Choi JH, Shin J, Park S. Discrepancies between home blood pressure and ambulatory blood pressure monitoring in apparent treatment-resistant hypertension: analysis from the Korean resistant hypertension cohort. Hypertens Res. 2025 Jan;48(1):37-48. doi: 10.1038/s41440-024-02017-7. Epub 2024 Nov 14.
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