Trial Outcomes & Findings for Central Sodium Sensing: Implications for Blood Pressure Regulation (NCT NCT05480722)
NCT ID: NCT05480722
Last Updated: 2025-12-08
Results Overview
Functional connectivity between sodium sensing circumventricular organs (subfornical organ (SFO) and organum vasculosum of the lamina terminalis(OVLT)) was calculated (expressed as the z-score). Functional connectivity is a measure of the the correlation (or synchronization) of the blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal time course between two brain regions. Pearson correlations were computed between the BOLD fMRI signal in the SFO and OVLT in a seed-to-seed functional connectivity analysis. Pearson correlations were converted to Z-scores using a Fisher's transform. A Z-score of 0 indicates no correlation between the BOLD fMRI signal between these 2 brain regions; a higher score indicates a greater, positive correlation between the BOLD fMRI signal in these 2 brain regions; a lower score indicates a greater, negative correlation between the fMRI signal in these 2 brain regions. This data does not have any clinical thresholds.
COMPLETED
NA
29 participants
Functional connectivity (FC) was calculated at baseline (~10 min). Then, participants received a 30-minute hypertonic saline infusion (HSI) with or without furosemide before. FC was calculated during the early (0-15 min) and late phase (15-30 min) of HSI.
2025-12-08
Participant Flow
29 participants were consented into the study. However, prior to starting an intervention, participants underwent a medical screening to ensure they qualify for the study. During this process, 7 participants failed the screening and 10 participants withdrew by choice. Thus, these 17 participants did not begin an intervention. This is why we only report a total of 12 participants (9+3) enrolled in the participant flow.
Participant milestones
| Measure |
Hypernatremia + Furosemide First, Then Hypernatremia Without Furosemide
Participants in this arm underwent blood-oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) on two separate days. On the first testing day, participants received a hypertonic saline infusion with NKCC2 antagonism (furosemide). On the second testing day, participants received a hypertonic saline infusion without NKCC2 antagonism (furosemide).
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Hypernatremia Without Furosemide First, Then Hypernatremia + Furosemide
Participants in this arm underwent blood-oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) on two separate days. On the first testing day, participants received a hypertonic saline infusion without NKCC2 antagonism (furosemide). On the second testing day, participants received a hypertonic saline infusion with NKCC2 antagonism (furosemide).
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|---|---|---|
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Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Central Sodium Sensing: Implications for Blood Pressure Regulation
Baseline characteristics by cohort
| Measure |
All Study Participants
n=6 Participants
All study participants who completed the hypertonic saline infusion protocol both with and without NKCC2 antagonism (furosemide). This is combining participants assigned to the Hypernatremia + Furosemide first, then Hypernatremia without Furosemide Arm and the Hypernatremia without Furosemide first, then Hypernatremia + Furosemide Arm.
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|---|---|
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Age, Continuous
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28 years
STANDARD_DEVIATION 8 • n=37 Participants
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Sex: Female, Male
Female
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3 Participants
n=37 Participants
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Sex: Female, Male
Male
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3 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
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2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=37 Participants
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|
Race (NIH/OMB)
White
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3 Participants
n=37 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=37 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=37 Participants
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Body Mass Index (BMI)
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26.3 kg/m^2
STANDARD_DEVIATION 2.3 • n=37 Participants
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PRIMARY outcome
Timeframe: Functional connectivity (FC) was calculated at baseline (~10 min). Then, participants received a 30-minute hypertonic saline infusion (HSI) with or without furosemide before. FC was calculated during the early (0-15 min) and late phase (15-30 min) of HSI.Functional connectivity between sodium sensing circumventricular organs (subfornical organ (SFO) and organum vasculosum of the lamina terminalis(OVLT)) was calculated (expressed as the z-score). Functional connectivity is a measure of the the correlation (or synchronization) of the blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal time course between two brain regions. Pearson correlations were computed between the BOLD fMRI signal in the SFO and OVLT in a seed-to-seed functional connectivity analysis. Pearson correlations were converted to Z-scores using a Fisher's transform. A Z-score of 0 indicates no correlation between the BOLD fMRI signal between these 2 brain regions; a higher score indicates a greater, positive correlation between the BOLD fMRI signal in these 2 brain regions; a lower score indicates a greater, negative correlation between the fMRI signal in these 2 brain regions. This data does not have any clinical thresholds.
Outcome measures
| Measure |
Hypertonic Saline Infusion Without Furosemide
n=6 Participants
Data from participants functional magnetic resonance imaging (fMRI) scan at which they received the hypertonic saline infusion without NKCC2 antagonism (furosemide).
|
Hypertonic Saline Infusion + Furosemide
n=6 Participants
Data from participants functional magnetic resonance imaging (fMRI) scan at which they received the hypertonic saline infusion with NKCC2 antagonism (furosemide).
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|---|---|---|
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Functional Connectivity Between the Subfornical Organ and Organum Vasculosum of the Lamina Terminalis (Z-score)
Baseline (Immediately pre-furosemide and/or hypertonic saline infusion)
|
0.258490 z-score
Standard Deviation 0.105129
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0.359145 z-score
Standard Deviation 0.268795
|
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Functional Connectivity Between the Subfornical Organ and Organum Vasculosum of the Lamina Terminalis (Z-score)
Early Phase (0-15 minutes of hypertonic saline infusion)
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0.207372 z-score
Standard Deviation 0.196048
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0.169055 z-score
Standard Deviation 0.169819
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Functional Connectivity Between the Subfornical Organ and Organum Vasculosum of the Lamina Terminalis (Z-score)
Late Phase (15-30 minutes of hypertonic saline infusion)
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0.272881 z-score
Standard Deviation 0.130301
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0.097043 z-score
Standard Deviation 0.066845
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Adverse Events
Hypernatremia + Furosemide
Hypernatremia Without Furosemide
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place