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

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ClinicalTrials.gov Identifier: NCT02078115
Recruitment Status : Unknown
Verified March 2014 by Yon Su Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yon Su Kim, Seoul National University Hospital

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.

Condition or disease
Chronic Kidney Disease Hypertension

Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Observational Study of Blood Pressure Control Pattern and the Impact on the Target Organ Damages
Study Start Date : April 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
chronic kidney disease, hypertension
20 <= age < 75 years 15 <= estimated glomerular filtration rate (GFR) < 90



Primary Outcome Measures :
  1. The change of blood pressure control pattern in patients with CKD [ Time Frame: 1 year after enrolling the last participant ]

Secondary Outcome Measures :
  1. 1) target organ damages in kidney and heart [ Time Frame: 1 year after enrolling the last participant ]
  2. 2) the relationship between the change of BP control pattern and the target organ damages [ Time Frame: 1 year after enrolling the last participant ]
  3. 3) assessment of related clinical factors with BP control pattern [ Time Frame: 1 year after enrolling the last participant ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
chronic kidney disease patients with hypertension
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078115


Contacts
Contact: Sung Kyun Kim, MD imnksk@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ran-hui Cha, MD       reginaprayer@gmail.com   
Sub-Investigator: Hajeong Lee, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Sung Kyun Kim, MD Hallym University Hospital

Responsible Party: Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02078115     History of Changes
Other Study ID Numbers: APRODITE-2
Boryung ( Other Grant/Funding Number: Boryung )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency