Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan (ESPECIAL)

This study is currently recruiting participants.
Verified September 2012 by Seoul National University Bundang Hospital
Sponsor:
Collaborators:
Daiichi Sankyo Inc.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Ho Jun Chin, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01552954
First received: February 24, 2012
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

Purpose of this study

  1. Intensive education for low salt diet will be enhance the anti-proteinuric effect of Olmesartan, a popular anti-hypertensive drug of angiotensin II receptor blocker, in Koreans compared to conventional prescription of medication.
  2. Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium excretion compared to control group, effectively.

Condition Intervention Phase
Hypertension
Chronic Kidney Disease
Microalbuminuria
Behavioral: Intensive education for low salt diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Low Sodium Intake on the Anti-proteinuric Efficacy of Olmesartan in Hypertensive Patients With Albuminuria Through Open-label Randomized Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Change in albuminuria as a spot urine albumin to creatinine ratio by intensive education of low salt diet during taking olmesartan [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    spot urine albumin to creatinine ratio


Secondary Outcome Measures:
  • The change of hemoglobin after prescription of Olmesartan is proportional to the change of albuminuria [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    hemoglobin

  • Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Na in 24 hour-urine collection

  • Intensive education for low salt diet induces the significant decrease of blood pressure in Intervention group compared to control group. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    blood pressures


Estimated Enrollment: 270
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive education of low salt diet
For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Behavioral: Intensive education for low salt diet
For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Other Names:
  • low salt diet
  • Angiotensin II converting enzyme
  • albuminuria
  • chronic kidney disease
No Intervention: Conventional diet group
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 19 years or more and 75 years or less
  • Hypertension patients: Patients whose blood pressure is 140/90mmHg and over, patients is newly diagnosed with hypertension or is prescribed antihypertensive medications.
  • Hypertensive patients verified 2 times or more of albuminuria 30 mg/g cr or more in a spot urine sample with interval of 1 week or more in recent 6 months
  • Estimated glomerular filtration rate (GFR) by Modification of Diet in Renal Disease (MDRD) equation 30 ml/min/1.73 m2 or more
  • Patients who give written consent to this study by oneself

Exclusion Criteria:

  • Blood pressure more than 160/100 mmHg
  • Pregnant
  • Serum potassium level more than 5.5 mEq/L at screening period
  • Patients with malignancy, acute cerebral infarction, acute myocardial infarction, unstable angina, percutanous coronary arterial intervention (PCI), or coronary artery bypass graft (CABG) in recent 6 months
  • Patients with diabetes mellitus
  • Patients who have an allergy to Olmesartan
  • Patients who were involved in other clinical trial in recent 1 month or are participated in screening period
  • Patients taking medication(s) of corticosteroid or immunosuppressant in a screening period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552954

Contacts
Contact: Ho Jun Chin, PhD 82317877025 mednep@snubh.org
Contact: Chun-Soo Lim, PhD 8228702120 cslimjy@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Kyeong ki, Korea, Republic of, 463787
Contact: Ho Jun Chin, PhD    82317877025    mednep@snubh.org   
Principal Investigator: Ho Jun Chin, PhD         
Dongguk University Ilsan Hospital Recruiting
Ilsan, Kyeongki, Korea, Republic of, 410773
Contact: Sung Joon Shin, PhD    82319617145    shine@duih.org   
Principal Investigator: Sung Joon Shin, PhD         
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156707
Contact: Chun-Soo Lim, Phd    8228702120    cslimjy@snu.ac.kr   
Principal Investigator: Chun-Soo Lim, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Contact: Dong Ki Kim, PhD    82220722303    dkkim@gmail.com   
Principal Investigator: Dong Ki Kim, PhD         
Sub-Investigator: Suhnggwon Kim, PhD         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137701
Contact: Bum Soon Choi, PhD    82222586040    sooncb@catholic.ac.kr   
Principal Investigator: Bum Soon Choi, PhD         
Kyung Hee University Recruiting
Seoul, Korea, Republic of, 134727
Contact: Sang-Ho Lee, PhD    821086504272    rulale@dreamwiz.com   
Principal Investigator: Sang Ho Lee, PhD         
Konkuk University School of Medicine Recruiting
Seoul, Korea, Republic of, 143729
Contact: Jung-Hwan Park, PhD    82220307528    20040019@kuh.ac.kr   
Principal Investigator: Jung-Hwan Park, PhD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Daiichi Sankyo Inc.
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Ho Jun Chin, PhD Seoul National University Bundang Hospital
Study Chair: Chun-Soo Lim, PhD SMG-SNU Boramae Medical Center
Principal Investigator: Dong Ki Kim, PhD Seoul National University Hospital
Principal Investigator: Suhnggwon Kim, PhD Seoul National University Hospital
Principal Investigator: Bum Soon Choi, PhD Seoul St. Mary's Hospital
Principal Investigator: Sang-Ho Lee, PhD Kyung Hee University
Principal Investigator: Jung-Hwan Park, PhD Konkuk University
Principal Investigator: Sung Joon Shin, PhD DongGuk University
  More Information

Publications:
Responsible Party: Ho Jun Chin, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01552954     History of Changes
Other Study ID Numbers: B-1112/142-008
Study First Received: February 24, 2012
Last Updated: September 5, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
hypertension
Chronic kidney disease
albuminuria
low salt diet
Angiotensin II receptor blocker

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Albuminuria
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin II
Olmesartan
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014