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

NCT01552954 | Completed Phase 4 Results

• 1 other identifier: B-1112/142-008
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 7

Brief Summary

Purpose of this study

1. 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. 2.Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium excretion compared to control group, effectively.

Conditions

Hypertension; Chronic Kidney Disease; Microalbuminuria

Keywords

hypertension; Chronic kidney disease; albuminuria; low salt diet; Angiotensin II receptor blocker

Outcome Measures

Primary Outcomes (1)

• ∆Albuminuria by 24-hour Urine Protein Excretion

  Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan \*In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were "mean" of all participants on specific study week, but "∆albuminuria (week 8 - week 16)" value was "mean" of ∆ values of "8 weeks-16 weeks" in each individuals. Therefore, values of 3 patients were excluded in "mean of ∆albuminuria (week 8 - week 16)". That's why simple subtraction (week 8 - week 16) of values are not matched with the data.

  changes from week 8 at week 16 (week 8 - week 16)

Secondary Outcomes (3)

• ∆Hemoglobin (0 Week - 16 Weeks)

  0 week, 16 weeks

• Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16

  week 8 and week 16

• Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16

  week 8 and week 16

Study Arms (2)

Intensive education of low salt diet

EXPERIMENTAL

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. (\*Intervention in this trial is the "intensity of education")

Behavioral: Intensive education of low salt diet

Conventional diet group

NO INTERVENTION

Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

Interventions

Intensive education of low salt diet BEHAVIORAL

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.

Also known as: low salt diet, Angiotensin II converting enzyme, albuminuria, chronic kidney disease

Intensive education of low salt diet

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, percutaneous 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Daiichi Sankyo: collaborator
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (7)

Seoul National University Bundang Hospital

Seongnam, Kyeong Ki, 463787, South Korea

Location

Dongguk University Ilsan Hospital

Ilsan, Kyeongki, 410773, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, 110744, South Korea

Location

Kyung Hee University

Seoul, Seoul, 134727, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Seoul, 137701, South Korea

Location

Konkuk University School of Medicine

Seoul, Seoul, 143729, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, Seoul, 156707, South Korea

Location

Related Publications (10)

• 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. doi: 10.1681/ASN.2007060693. Epub 2008 Feb 13.

  PMID: 18272844 BACKGROUND

• 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. doi: 10.2337/dc08-2297. Epub 2009 Jun 23.

  PMID: 19549737 BACKGROUND

• 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. doi: 10.1161/HYPERTENSIONAHA.109.133223. Epub 2009 Jul 20.

  PMID: 19620514 BACKGROUND

• 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. doi: 10.1136/bmj.297.6644.319.

  PMID: 3416162 BACKGROUND

• 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. doi: 10.1161/01.HYP.0000172662.12480.7f. Epub 2005 Jun 27.

  PMID: 15983240 BACKGROUND

• Hwang JH, Oh S, Chin HJ, Kim S, Kim DK, Kim S, Park JH, Shin SJ, Lee SH, Choi BS, Lim CS. Comparison of the performance of currently used estimated glomerular filtration rate equations with 24-hour urine creatinine clearance: sample analysis of randomised controlled trial participants. BMJ Open. 2023 Aug 23;13(8):e067398. doi: 10.1136/bmjopen-2022-067398.

  PMID: 37612109 DERIVED

• McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

  PMID: 34164803 DERIVED

• Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

  PMID: 33782940 DERIVED

• An JN, Hwang JH, Lee JP, Chin HJ, Kim S, Kim DK, Kim S, Park JH, Shin SJ, Lee SH, Choi BS, Lim CS. The Decrement of Hemoglobin Concentration with Angiotensin II Receptor Blocker Treatment Is Correlated with the Reduction of Albuminuria in Non-Diabetic Hypertensive Patients: Post-Hoc Analysis of ESPECIAL Trial. PLoS One. 2015 Jun 22;10(6):e0128632. doi: 10.1371/journal.pone.0128632. eCollection 2015.

  PMID: 26098847 DERIVED

• Baek SH, Kim S, Kim DK, Park JH, Shin SJ, Lee SH, Choi BS, Chin HJ, Kim S, Lim CS. A low-salt diet increases the estimated net endogenous acid production in nondiabetic chronic kidney disease patients treated with angiotensin receptor blockade. Nephron Clin Pract. 2014;128(3-4):407-13. doi: 10.1159/000369558. Epub 2014 Dec 18.

  PMID: 25531146 DERIVED

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic; Albuminuria

Interventions

Diet, Sodium-Restricted; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; 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; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

The major limitation of this study is that we used a 24-hour volume urine collected at a single time point for each follow-up visit. Urine excretion can be influenced by the sodium intake of individual patients at certain point.

Results Point of Contact

• Title: Ho Jun Chin
• Organization: Department of Internal Medicine, Seoul National University Bundang Hospital

mednep@snubh.org

+82-10-7360-7025

Study Officials

• Ho Jun Chin, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Chun-Soo Lim, PhD

  SMG-SNU Boramae Medical Center

  STUDY CHAIR

• 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

  Kyunghee University

  PRINCIPAL INVESTIGATOR

• Jung-Hwan Park, PhD

  Konkuk University

  PRINCIPAL INVESTIGATOR

• Sung Joon Shin, PhD

  DongGuk University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 13, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 18, 2014
• Results First Posted: December 18, 2014

Record last verified: 2014-12

Locations

KR (7)