Trial Outcomes & Findings for Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan (NCT NCT01552954)
NCT ID: NCT01552954
Last Updated: 2014-12-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
269 participants
Primary outcome timeframe
changes from week 8 at week 16 (week 8 - week 16)
Results posted on
2014-12-18
Participant Flow
Patients were selected from 7 centers in Korea (Seoul National University Boramae Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Konkuk University Hospital, Dongguk University Ilsan Hospital, Kyung Hee University Medical Center, and Seoul St. Mary's Hospital) and enrolled from Mar. 2012 to Mar. 2013.
We screened 312 patients before 8 weeks of study initiation, and 269 patients were enrolled. During the 1st 8 weeks of this study (ARB run-in), 13 patients were withdrawn. After that, 256 patients were randomized, 11 participants were dropped out between 8th week and 16th week, and 245 who completed the trial were included in the analysis .
Participant milestones
| Measure |
Conventional Education of Low-salt Diet Group
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
125
|
|
Overall Study
COMPLETED
|
126
|
119
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Conventional Education of Low-salt Diet Group
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
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.
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
diagnosed DM
|
1
|
0
|
Baseline Characteristics
Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan
Baseline characteristics by cohort
| Measure |
Conventional Education of Low-salt Diet Group
n=131 Participants
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
n=125 Participants
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.
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.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
131 participants
n=5 Participants
|
125 participants
n=7 Participants
|
256 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: changes from week 8 at week 16 (week 8 - week 16)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.
Outcome measures
| Measure |
Conventional Education of Low-salt Diet Group
n=126 Participants
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
n=119 Participants
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.
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.
|
|---|---|---|
|
∆Albuminuria by 24-hour Urine Protein Excretion
24hr-urine albumin (8th week)
|
483.5 mg/day
Standard Deviation 646.7
|
569.9 mg/day
Standard Deviation 718.9
|
|
∆Albuminuria by 24-hour Urine Protein Excretion
24hr-urine albumin (16th week);n=124, 118
|
487.3 mg/day
Standard Deviation 688.8
|
417.4 mg/day
Standard Deviation 597.0
|
|
∆Albuminuria by 24-hour Urine Protein Excretion
Mean of ∆albuminuria (week 8-week 16); n=124, 118
|
-0.4 mg/day
Standard Deviation 371.9
|
154.0 mg/day
Standard Deviation 489.6
|
SECONDARY outcome
Timeframe: 0 week, 16 weeksThe change of hemoglobin after prescription of Olmesartan
Outcome measures
| Measure |
Conventional Education of Low-salt Diet Group
n=126 Participants
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
n=119 Participants
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.
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.
|
|---|---|---|
|
∆Hemoglobin (0 Week - 16 Weeks)
Hemoglobin (week 0)
|
13.8 g/dL
Standard Deviation 1.7
|
14.0 g/dL
Standard Deviation 1.8
|
|
∆Hemoglobin (0 Week - 16 Weeks)
Hemoglobin (week 8)
|
13.5 g/dL
Standard Deviation 1.8
|
13.7 g/dL
Standard Deviation 1.7
|
|
∆Hemoglobin (0 Week - 16 Weeks)
Hemoglobin (week 16)
|
13.3 g/dL
Standard Deviation 1.7
|
13.4 g/dL
Standard Deviation 1.7
|
|
∆Hemoglobin (0 Week - 16 Weeks)
Hemoglobin changes from week 0 at week 16
|
0.46 g/dL
Standard Deviation 0.90
|
0.62 g/dL
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: week 8 and week 16Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16
Outcome measures
| Measure |
Conventional Education of Low-salt Diet Group
n=126 Participants
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
n=119 Participants
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.
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.
|
|---|---|---|
|
Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16
week 8
|
155.5 mEq/day
Standard Deviation 71.1
|
157.4 mEq/day
Standard Deviation 74.7
|
|
Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16
week 16; n=124, 118
|
147.1 mEq/day
Standard Deviation 66.1
|
122.1 mEq/day
Standard Deviation 59.9
|
|
Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16
∆Na excretion (week 8 - week 16);n=124, 118
|
9.0 mEq/day
Standard Deviation 54.5
|
35.4 mEq/day
Standard Deviation 64.4
|
SECONDARY outcome
Timeframe: week 8 and week 16Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group
Outcome measures
| Measure |
Conventional Education of Low-salt Diet Group
n=126 Participants
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
n=119 Participants
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.
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.
|
|---|---|---|
|
Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
Systolic BP at week 8
|
121.8 mm Hg
Standard Deviation 18.4
|
122.1 mm Hg
Standard Deviation 14.0
|
|
Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
Systolic BP at week 16
|
121.2 mm Hg
Standard Deviation 14.9
|
120.4 mm Hg
Standard Deviation 14.9
|
|
Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
sBP changes from week 8 at week 16
|
0.6 mm Hg
Standard Deviation 15.1
|
1.7 mm Hg
Standard Deviation 14.6
|
|
Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
Diastolic BP at week 8
|
73.4 mm Hg
Standard Deviation 11.6
|
73.6 mm Hg
Standard Deviation 11.0
|
|
Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
Diastolic BP at week 16
|
74.8 mm Hg
Standard Deviation 10.5
|
73.1 mm Hg
Standard Deviation 10.4
|
|
Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
dBP changes from week 8 at week 16
|
-0.7 mm Hg
Standard Deviation 10.0
|
0.5 mm Hg
Standard Deviation 9.8
|
Adverse Events
Conventional Education of Low-salt Diet Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intensive Education of Low-salt Diet Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Education of Low-salt Diet Group
n=131 participants at risk
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
|
Intensive Education of Low-salt Diet Group
n=125 participants at risk
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.
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.
|
|---|---|---|
|
Renal and urinary disorders
Elevated serum creatinine
|
0.00%
0/131 • from week 8 to week 16 (for 8 weeks)
|
1.6%
2/125 • Number of events 2 • from week 8 to week 16 (for 8 weeks)
|
|
Nervous system disorders
Headache
|
0.76%
1/131 • Number of events 1 • from week 8 to week 16 (for 8 weeks)
|
0.00%
0/125 • from week 8 to week 16 (for 8 weeks)
|
Additional Information
Ho Jun Chin
Department of Internal Medicine, Seoul National University Bundang Hospital
Phone: +82-10-7360-7025
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place