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NCT02078115 Clinical Trial

Assessment of Blood Pressure Control and Target Organ Damage in Patients With Chronic Kidney Disease and Hypertension -II

Hypertension Clinical Trial

Official title:
Observational Study of Blood Pressure Control Pattern and the Impact on the Target Organ Damages

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02078115
Other study ID # APRODITE-2
Secondary ID Boryung
Status Recruiting
Phase N/A
First received February 5, 2014
Last updated March 3, 2014
Start date April 2013
Est. completion date July 2015

Study information
Verified date March 2014
Source Seoul National University Hospital
Contact Sung Kyun Kim, MD
Email imnksk@gmail.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility Inclusion Criteria:

1. with informed consent

2. 20 <= age < 75 years

3. diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months

4. all-cause chronic kidney disease patients with 15 <= estimated GFR < 90

5. no change of anti-hypertensive drugs within 2 weeks and good compliance

Exclusion Criteria:

1. changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly

2. had acute kidney injury/hospitalization

3. had a proteinuria of > 6 g/day (spot urine protein to creatinine ratio > 6.0 g/g Cr)

4. had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient

5. had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus

6. were pregnant/lactating women

7. were night shift workers.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change of blood pressure control pattern in patients with CKD 1 year after enrolling the last participant No
Secondary 1) target organ damages in kidney and heart 1 year after enrolling the last participant No
Secondary 2) the relationship between the change of BP control pattern and the target organ damages 1 year after enrolling the last participant No
Secondary 3) assessment of related clinical factors with BP control pattern 1 year after enrolling the last participant No
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