Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan - Full Text View

Purpose

Purpose of this study

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.
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:

MedlinePlus related topics: Chronic Kidney Disease Dietary Sodium High Blood Pressure Urine and Urination

Drug Information available for: Sodium chloride Olmesartan Olmesartan medoxomil

U.S. FDA Resources

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.

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:

Vogt L, Waanders F, Boomsma F, de Zeeuw D, Navis G. Effects of dietary sodium and hydrochlorothiazide on the antiproteinuric efficacy of losartan. J Am Soc Nephrol. 2008 May;19(5):999-1007. Epub 2008 Feb 13.

Ekinci EI, Thomas G, Thomas D, Johnson C, Macisaac RJ, Houlihan CA, Finch S, Panagiotopoulos S, O'Callaghan C, Jerums G. Effects of salt supplementation on the albuminuric response to telmisartan with or without hydrochlorothiazide therapy in hypertensive patients with type 2 diabetes are modulated by habitual dietary salt intake. Diabetes Care. 2009 Aug;32(8):1398-403. Epub 2009 Jun 23.

He FJ, Marciniak M, Visagie E, Markandu ND, Anand V, Dalton RN, MacGregor GA. Effect of modest salt reduction on blood pressure, urinary albumin, and pulse wave velocity in white, black, and Asian mild hypertensives. Hypertension. 2009 Sep;54(3):482-8. Epub 2009 Jul 20.

[No authors listed] Intersalt: an international study of electrolyte excretion and blood pressure. Results for 24 hour urinary sodium and potassium excretion. Intersalt Cooperative Research Group. BMJ. 1988 Jul 30;297(6644):319-28.

Swift PA, Markandu ND, Sagnella GA, He FJ, MacGregor GA. Modest salt reduction reduces blood pressure and urine protein excretion in black hypertensives: a randomized control trial. Hypertension. 2005 Aug;46(2):308-12. Epub 2005 Jun 27.

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 May 16, 2013

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