Trial Outcomes & Findings for Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT) (NCT NCT04717336)
NCT ID: NCT04717336
Last Updated: 2025-04-27
Results Overview
Mean change in vascular function was measured by Pulse Wave Velocity (PWV) using the SphygmoCor XCEL. PWV was determined by recording the pulse waves of the carotid and femoral arteries and calculating the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. The distance was measured with a non-stretchable tape from the suprasternal notch to the carotid site and from the suprasternal notch to the femoral site. The former distance was subtracted from the latter and used in the calculation of PWV. High PWV is directly associated with increased arterial stiffness, reflecting reduced elasticity of the arterial walls.
COMPLETED
NA
36 participants
Baseline, Week 2, Week 5 and Week 7
2025-04-27
Participant Flow
Participant milestones
| Measure |
Sodium Chloride Then Placebo
Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Placebo at 3 pills per day for a total of 3 grams for two weeks.
|
Placebo Then Sodium Chloride
Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks.
|
|---|---|---|
|
Period 1: Baseline to Week 2
STARTED
|
20
|
16
|
|
Period 1: Baseline to Week 2
COMPLETED
|
18
|
14
|
|
Period 1: Baseline to Week 2
NOT COMPLETED
|
2
|
2
|
|
Washout: Week 2 to Week 5
STARTED
|
18
|
14
|
|
Washout: Week 2 to Week 5
COMPLETED
|
16
|
12
|
|
Washout: Week 2 to Week 5
NOT COMPLETED
|
2
|
2
|
|
Period 2: Week 5 to Week 7
STARTED
|
16
|
12
|
|
Period 2: Week 5 to Week 7
COMPLETED
|
16
|
12
|
|
Period 2: Week 5 to Week 7
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sodium Chloride Then Placebo
Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Placebo at 3 pills per day for a total of 3 grams for two weeks.
|
Placebo Then Sodium Chloride
Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks.
|
|---|---|---|
|
Period 1: Baseline to Week 2
Withdrawal by Subject
|
2
|
2
|
|
Washout: Week 2 to Week 5
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT)
Baseline characteristics by cohort
| Measure |
Sodium Chloride Then Placebo
n=20 Participants
Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Placebo at 3 pills per day for a total of 3 grams for two weeks.
|
Placebo Then Sodium Chloride
n=16 Participants
Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks.
|
Total
n=36 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
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 5 and Week 7Population: Analysis includes only those participants that completed the Pulse Wave Velocity at every visit (n=23).
Mean change in vascular function was measured by Pulse Wave Velocity (PWV) using the SphygmoCor XCEL. PWV was determined by recording the pulse waves of the carotid and femoral arteries and calculating the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. The distance was measured with a non-stretchable tape from the suprasternal notch to the carotid site and from the suprasternal notch to the femoral site. The former distance was subtracted from the latter and used in the calculation of PWV. High PWV is directly associated with increased arterial stiffness, reflecting reduced elasticity of the arterial walls.
Outcome measures
| Measure |
Sodium Chloride Then Placebo
n=13 Participants
Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Placebo at 3 pills per day for a total of 3 grams for two weeks.
|
Placebo Then Sodium Chloride
n=10 Participants
Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks.
|
|---|---|---|
|
Mean Change in Vascular Function Measured by Pulse Wave Velocity
Baseline
|
7.08 m/s
Standard Deviation 1.50
|
7.13 m/s
Standard Deviation 0.81
|
|
Mean Change in Vascular Function Measured by Pulse Wave Velocity
Week 5
|
6.88 m/s
Standard Deviation 1.06
|
6.86 m/s
Standard Deviation 1.30
|
|
Mean Change in Vascular Function Measured by Pulse Wave Velocity
Week 2
|
7.34 m/s
Standard Deviation 0.88
|
7.07 m/s
Standard Deviation 0.96
|
|
Mean Change in Vascular Function Measured by Pulse Wave Velocity
Week 7
|
7.03 m/s
Standard Deviation 1.27
|
6.70 m/s
Standard Deviation 0.95
|
Adverse Events
Sodium Chloride
Placebo
Wash-Out Period
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sodium Chloride
n=32 participants at risk
Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks.
|
Placebo
n=32 participants at risk
Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks.
|
Wash-Out Period
n=32 participants at risk
Participants do not take any study intervention for this washout period.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/32 • 7 weeks
|
3.1%
1/32 • Number of events 1 • 7 weeks
|
0.00%
0/32 • 7 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • 7 weeks
|
0.00%
0/32 • 7 weeks
|
0.00%
0/32 • 7 weeks
|
Additional Information
Georg Aue, MD
The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place