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

NCT02078115 | Unknown

• 2 other identifiers: APRODITE-2Boryung
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Hypertension

Outcome Measures

Primary Outcomes (1)

• The change of blood pressure control pattern in patients with CKD

  1 year after enrolling the last participant

Secondary Outcomes (3)

• 1) target organ damages in kidney and heart

  1 year after enrolling the last participant

• 2) the relationship between the change of BP control pattern and the target organ damages

  1 year after enrolling the last participant

• 3) assessment of related clinical factors with BP control pattern

  1 year after enrolling the last participant

Study Arms (1)

chronic kidney disease, hypertension

20 \<= age \< 75 years 15 \<= estimated glomerular filtration rate (GFR) \< 90

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

chronic kidney disease patients with hypertension

You may qualify if:

• with informed consent
• \<= age \< 75 years
• diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months
• all-cause chronic kidney disease patients with 15 \<= estimated GFR \< 90
• no change of anti-hypertensive drugs within 2 weeks and good compliance

You may not qualify if:

• changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly
• had acute kidney injury/hospitalization
• had a proteinuria of \> 6 g/day (spot urine protein to creatinine ratio \> 6.0 g/g Cr)
• had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient
• had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus
• were pregnant/lactating women
• were night shift workers.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sung Kyun Kim, MD

  Hallym University Hospital

  STUDY DIRECTOR

Central Study Contacts

Sung Kyun Kim, MD

CONTACT

imnksk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: March 5, 2014
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

KR (1)