Trial Outcomes & Findings for Tissue Sodium in Pre-hypertensive Patients (NCT NCT02236520)
NCT ID: NCT02236520
Last Updated: 2019-05-22
Results Overview
NaMRI is a sensitive laboratory assessment of the concentration of sodium in tissue
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
baseline and 8 weeks
Results posted on
2019-05-22
Participant Flow
Participant milestones
| Measure |
Spironolactone
50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks
Spironolactone
|
Chlorthalidone
25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks
Chlorthalidone
|
Diet
diet of 6 g salt per day for 8 weeks
Diet
|
Placebo
placebo capsule administered orally 1 per day for 8 weeks
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
8
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
0
|
1
|
Reasons for withdrawal
| Measure |
Spironolactone
50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks
Spironolactone
|
Chlorthalidone
25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks
Chlorthalidone
|
Diet
diet of 6 g salt per day for 8 weeks
Diet
|
Placebo
placebo capsule administered orally 1 per day for 8 weeks
Placebo
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
5
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Tissue Sodium in Pre-hypertensive Patients
Baseline characteristics by cohort
| Measure |
Spironolactone
n=16 Participants
50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks
Spironolactone
|
Chlorthalidone
n=13 Participants
25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks
Chlorthalidone
|
Diet
n=15 Participants
diet of 6 g salt per day for 8 weeks
Diet
|
Placebo
n=15 Participants
placebo capsule administered orally 1 per day for 8 weeks
Placebo
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 11 • n=93 Participants
|
49 years
STANDARD_DEVIATION 9 • n=4 Participants
|
49 years
STANDARD_DEVIATION 13 • n=27 Participants
|
48 years
STANDARD_DEVIATION 14 • n=483 Participants
|
48 years
STANDARD_DEVIATION 12 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
58 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
13 participants
n=4 Participants
|
15 participants
n=27 Participants
|
15 participants
n=483 Participants
|
59 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 weeksNaMRI is a sensitive laboratory assessment of the concentration of sodium in tissue
Outcome measures
| Measure |
Spironolactone
n=14 Participants
50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks
Spironolactone
|
Chlorthalidone
n=8 Participants
25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks
Chlorthalidone
|
Diet
n=15 Participants
diet of 6 g salt per day for 8 weeks
Diet
|
Placebo
n=14 Participants
placebo capsule administered orally 1 per day for 8 weeks
Placebo
|
|---|---|---|---|---|
|
Change in Tissue Sodium Concentration Measured Using Sodium Magnetic Resonance Imaging (NaMRI)
|
-0.202 mmol/L
Interval -0.973 to 1.667
|
0.430 mmol/L
Interval -1.085 to 1.285
|
-1.745 mmol/L
Interval -2.157 to -0.219
|
-0.407 mmol/L
Interval -2.108 to 1.088
|
Adverse Events
Spironolactone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Chlorthalidone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Diet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spironolactone
n=16 participants at risk
50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks
Spironolactone
|
Chlorthalidone
n=13 participants at risk
25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks
Chlorthalidone
|
Diet
n=15 participants at risk
diet of 6 g salt per day for 8 weeks
Diet
|
Placebo
n=15 participants at risk
placebo capsule administered orally 1 per day for 8 weeks
Placebo
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/16 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
6.7%
1/15 • Number of events 1 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/16 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Endocrine disorders
hypoglycemia
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Gastrointestinal disorders
gastrointestinal upset
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Gastrointestinal disorders
nausea
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Cardiac disorders
tachycardia
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place