Trial Outcomes & Findings for Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure (NCT NCT04334668)
NCT ID: NCT04334668
Last Updated: 2025-05-04
Results Overview
Measured in kilograms
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline to 96 hours
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Oral Sodium Chloride
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
|
Placebo
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
34
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure
Baseline characteristics by cohort
| Measure |
Oral Sodium Chloride
n=34 Participants
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
|
Placebo
n=31 Participants
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
|
Total
n=65 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 96 hoursMeasured in kilograms
Outcome measures
| Measure |
Oral Sodium Chloride
n=34 Participants
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
|
Placebo
n=31 Participants
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
|
|---|---|---|
|
Change in Weight
|
-3.9 Kilograms
Standard Deviation 4.3
|
-4.6 Kilograms
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline to 96 hoursMeasured in milliequivalents per Liter
Outcome measures
| Measure |
Oral Sodium Chloride
n=34 Participants
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
|
Placebo
n=31 Participants
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
|
|---|---|---|
|
Change in Creatinine
|
0.038 mEq/L
Standard Deviation 0.39
|
0.15 mEq/L
Standard Deviation 0.44
|
Adverse Events
Oral Sodium Chloride
Serious events: 7 serious events
Other events: 4 other events
Deaths: 3 deaths
Placebo
Serious events: 7 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Oral Sodium Chloride
n=34 participants at risk
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
|
Placebo
n=31 participants at risk
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
|
|---|---|---|
|
Renal and urinary disorders
Worsening Renal Function
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
Cardiac disorders
Low output and elevated filling pressure
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
General disorders
Hypokalemia
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
Readmission for weight gain
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
Cardiac disorders
ICU transfer
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
Readmitted
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
Cardiac disorders
VF arrest
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
Readmission
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
Respiratory, thoracic and mediastinal disorders
COVID 19 infection
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
Respiratory, thoracic and mediastinal disorders
ICU transfer
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
General disorders
Leukocytosis and worsening renal function
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
General disorders
Respiratory decompensation
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
Uncontrolled dyspnea
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
General disorders
ICU transfer
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
ICU
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
Renal and urinary disorders
Increase in creatinine
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
Cardiac disorders
ICU
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
Other adverse events
| Measure |
Oral Sodium Chloride
n=34 participants at risk
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
|
Placebo
n=31 participants at risk
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
|
|---|---|---|
|
General disorders
Gout Flare up
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
hypokalemia
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
General disorders
Hypokalemia, VF arrest
|
0.00%
0/34 • Enrollment to 90 days post enrollment
|
3.2%
1/31 • Number of events 1 • Enrollment to 90 days post enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Transferred to ICU
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
General disorders
Hyponatremia
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
2.9%
1/34 • Number of events 1 • Enrollment to 90 days post enrollment
|
0.00%
0/31 • Enrollment to 90 days post enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place