Blood PressureSABRENCT03636490
Stress, Salt Excretion, and Nighttime Blood Pressure
A study testing Psychological Stress Intervention in people with Blood Pressure and Psychological Stress, run by Columbia University at 1 site in United States.
Trial summary
The study will examine urinary sodium excretion induced by psychological stress and its diurnal pattern as a novel biological mechanism that may underlie an abnormal diurnal pattern of blood pressure. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Psychological Stress
- What is being tested?
- Psychological Stress Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Screening mean blood pressure less than or equal to 160/105 mm Hg
Who cannot join
- History of overt cardiovascular disease (coronary heart disease, stroke, peripheral arterial disease, heart failure, permanent or recurring arrhythmia)
- History of secondary hypertension
- History of other major medical condition (cancer, rheumatologic diseases, immunologic diseases, etc.)
- Taking anti-hypertensive medications or other medications that are known to substantially affect blood pressure (e.g. steroids, chronic anti-inflammatory medications, etc.)
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center - Shimbo Hypertension Lab
New York, New York, 10032
About this study
Official title: Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure
The study will examine urinary sodium excretion induced by psychological stress and its diurnal pattern as a novel biological mechanism that may underlie an abnormal diurnal pattern of blood pressure. The study will test the hypotheses that lower stress-induced sodium excretion is associated with an abnormal diurnal pattern of sodium excretion, and that an abnormal diurnal pattern of sodium excretion is associated with an abnormal diurnal pattern of blood pressure.
Primary Aim 1: To examine the association between urinary sodium excretion after provoked psychological stress and the diurnal pattern of sodium excretion.
Read more
Primary Aim 2: To examine the association between the diurnal pattern of sodium excretion and the diurnal pattern of BP.
Secondary Aim: To examine whether the association between urinary sodium excretion after provoked stress and the diurnal pattern of sodium excretion is modified by ecological momentary levels of perceived stress, experienced during the daytime period.
Exploratory Aim: To determine the socio-demographic, behavioral, and psychological traits, chronic stress, and biological stress-related factors that are associated with lower stress-induced sodium excretion. Identification of these factors will help determine who is at risk for having a differential sodium excretion response to psychological stress.
Read the detailed description
Blood pressure (BP) has a diurnal rhythm; it is normally highest during the daytime period and lowest during the nighttime period (BP dipping). The diurnal pattern of BP over a 24-hour period can be assessed using ambulatory BP monitoring (ABPM). Evidence indicates that an abnormal diurnal pattern of BP on ABPM, defined by reduced BP dipping or elevated nighttime BP, is associated with an increased risk of cardiovascular disease (CVD) events.
Psychological stress occurs when an individual perceives that the environmental demands exceed his/her adaptive capacity. An individual's response to events that are representative of this overload, such as perceived stress and negative affect including anger, hostility, depression, vital exhaustion, and symptoms of posttraumatic stress disorder, are associated with reduced BP dipping and/or higher nighttime BP. Exposure to environmental factors which tax an individual's ability to cope, including lower socioeconomic status, job strain, and perceived racism, are also associated with reduced BP dipping and/or higher nighttime BP. This study will examine the disruption of the normal diurnal pattern of sodium excretion by psychological stress as a novel biological mechanism underlying an abnormal diurnal pattern of BP.
The study will be conducted both in the laboratory and in the naturalistic environment with a multi-ethnic sample of 211 adult community participants from upper Manhattan who do not have a history of CVD, diabetes, chronic kidney disease, or another major medical condition and are not taking antihypertensive medication. During a laboratory visit, urinary sodium excretion in response to mental stress tasks will be examined.
- Conditions
- Blood Pressure, Psychological Stress
- Being tested
- Psychological Stress Intervention
- Keywords
- Non-Dipping Blood Pressure
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Stress InterventionBehavioural
Also called Provoked Psychological Stress
All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Stress | Experimental | All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks.
Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period. Receives: Behavioral: Psychological Stress Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)
Measured: Over 24-hour ambulatory period
Systolic Blood Pressure Dipping (Aim 2)
Systolic blood pressure (SBP) dipping refers to the normal physiological decline in SBP during nighttime sleep. SBP dipping (%) was calculated as 100 * (mean awake SBP - mean asleep SBP) / (mean awake SBP).
Measured: Over 24-hour ambulatory period
Secondary outcomes (10)
Mean Perceived Stress Level
This is to measure the ecological stress level for the awake period during which the participants' sodium excretion is monitored. A 10-point Visual Analog Scale (VAS) (0=Not at all, 5=Moderately, and 10=Extremely) was used to assess stress.
Measured: Over 24-hour ambulatory period
24-hour Sodium Excretion
Rate of sodium excretion, measured from urine collected from participants during the ambulatory period.
Measured: Over 24-hour ambulatory period
24-hour Potassium Excretion
Rate of potassium excretion, measured from urine collected from participants during the ambulatory period.
Measured: Over 24-hour ambulatory period
24-hour Creatinine Clearance
Rate of creatine clearance, measured from urine collected from participants during the ambulatory period.
Measured: Over 24-hour ambulatory period
Fractional Excretion of Sodium
Fractional excretion of sodium is the amount of sodium that leaves the body through urine compared to the amount filtered and reabsorbed by the kidney.
Measured: Over 24-hour ambulatory period
EMA Stress
10-point Ecological Momentary Assessment (EMA) measures self-reported stress through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse stress. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.
Measured: Over 24-hour ambulatory period
EMA Anger
10-point Ecological Momentary Assessment (EMA) measures self-reported anger through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse anger. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.
Measured: Over 24-hour ambulatory period
EMA Aggravation
10-point Ecological Momentary Assessment (EMA) measures self-reported aggravation/irritation through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse aggravation. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.
Measured: Over 24-hour ambulatory period
EMA Anxiety
10-point Ecological Momentary Assessment (EMA) measures self-reported anxiety through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse anxiety. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.
Measured: Over 24-hour ambulatory period
EMA Depressed
10-point Ecological Momentary Assessment (EMA) measures self-reported sadness/depression through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse depression. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.
Measured: Over 24-hour ambulatory period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start16 Nov 2018
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daichi Shimbo, Columbia University
- Investigators
- Daichi Shimbo, MD, Principal investigator, Professor of Medicine, Dept of Med Beh Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636490
- Sponsor's protocol ID
- AAAS0154
- Other IDs
- 1R01HL137818-01A1
- Acronym
- SABRE
- Status last verified
- Apr 2025
- First submitted
- 9 Aug 2018
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fang C, Barrett M, Cepeda M, Choi E, Dong M, Frangaj B, Juraschek SP, LaRocca A, McGoldrick MT, Mercado Y, Pham P, Schwartz JE, Seid H, Thomas SJ, Shimbo D. Psychological Stress and the Diurnal Patterns of Sodium Excretion and Blood Pressure: Results From the SABRE Study. J Am Heart Assoc. 2026 Oct 16:e050471. doi: 10.1161/JAHA.126.050471. Online ahead of print.
PubMed 42885782
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure
- ClinicalTrials.gov ID
- NCT03636490
- Acronym / sponsor ID
- SABRE / AAAS0154
- Conditions
- Blood Pressure, Psychological Stress
- Keywords
- Non-Dipping Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine urinary sodium excretion induced by psychological stress and its diurnal pattern as a novel biological mechanism that may underlie an abnormal diurnal pattern of blood pressure. The study will test the hypotheses that lower stress-induced sodium excretion is associated with an abnormal diurnal pattern of sodium excretion, and that an abnormal diurnal pattern of sodium excretion is associated with an abnormal diurnal pattern of blood pressure.
Primary Aim 1: To examine the association between urinary sodium excretion after provoked psychological stress and the diurnal pattern of sodium excretion.
Primary Aim 2: To examine the association between the diurnal pattern of sodium excretion and the diurnal pattern of BP.
Secondary Aim: To examine whether the association between urinary sodium excretion after provoked stress and the diurnal pattern of sodium excretion is modified by ecological momentary levels of perceived stress, experienced during the daytime period.
Exploratory Aim: To determine the socio-demographic, behavioral, and psychological traits, chronic stress, and biological stress-related factors that are associated with lower stress-induced sodium excretion. Identification of these factors will help determine who is at risk for having a differential sodium excretion response to psychological stress.
Detailed description
Blood pressure (BP) has a diurnal rhythm; it is normally highest during the daytime period and lowest during the nighttime period (BP dipping). The diurnal pattern of BP over a 24-hour period can be assessed using ambulatory BP monitoring (ABPM). Evidence indicates that an abnormal diurnal pattern of BP on ABPM, defined by reduced BP dipping or elevated nighttime BP, is associated with an increased risk of cardiovascular disease (CVD) events.
Psychological stress occurs when an individual perceives that the environmental demands exceed his/her adaptive capacity. An individual's response to events that are representative of this overload, such as perceived stress and negative affect including anger, hostility, depression, vital exhaustion, and symptoms of posttraumatic stress disorder, are associated with reduced BP dipping and/or higher nighttime BP. Exposure to environmental factors which tax an individual's ability to cope, including lower socioeconomic status, job strain, and perceived racism, are also associated with reduced BP dipping and/or higher nighttime BP. This study will examine the disruption of the normal diurnal pattern of sodium excretion by psychological stress as a novel biological mechanism underlying an abnormal diurnal pattern of BP.
The study will be conducted both in the laboratory and in the naturalistic environment with a multi-ethnic sample of 211 adult community participants from upper Manhattan who do not have a history of CVD, diabetes, chronic kidney disease, or another major medical condition and are not taking antihypertensive medication. During a laboratory visit, urinary sodium excretion in response to mental stress tasks will be examined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Psychological Stress | Experimental | Behavioral: Psychological Stress InterventionAll enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21 years or older
- Screening mean blood pressure less than or equal to 160/105 mm Hg
Key exclusion criteria (5 listed)
- History of overt cardiovascular disease (coronary heart disease, stroke, peripheral arterial disease, heart failure, permanent or recurring arrhythmia)
- History of secondary hypertension
- History of other major medical condition (cancer, rheumatologic diseases, immunologic diseases, etc.)
- Taking anti-hypertensive medications or other medications that are known to substantially affect blood pressure (e.g. steroids, chronic anti-inflammatory medications, etc.)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Stress InterventionAlso: Provoked Psychological StressAll enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. | Behavioural | Psychological Stress |
Primary outcome
Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)
Time frame: Over 24-hour ambulatory period
Systolic Blood Pressure Dipping (Aim 2)
Time frame: Over 24-hour ambulatory period
Systolic blood pressure (SBP) dipping refers to the normal physiological decline in SBP during nighttime sleep. SBP dipping (%) was calculated as 100 * (mean awake SBP - mean asleep SBP) / (mean awake SBP).
10 secondary outcomes
Mean Perceived Stress Level
Time frame: Over 24-hour ambulatory period
24-hour Sodium Excretion
Time frame: Over 24-hour ambulatory period
24-hour Potassium Excretion
Time frame: Over 24-hour ambulatory period
24-hour Creatinine Clearance
Time frame: Over 24-hour ambulatory period
Fractional Excretion of Sodium
Time frame: Over 24-hour ambulatory period
EMA Stress
Time frame: Over 24-hour ambulatory period
EMA Anger
Time frame: Over 24-hour ambulatory period
EMA Aggravation
Time frame: Over 24-hour ambulatory period
EMA Anxiety
Time frame: Over 24-hour ambulatory period
EMA Depressed
Time frame: Over 24-hour ambulatory period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42885782Fang C, Barrett M, Cepeda M, Choi E, Dong M, Frangaj B, Juraschek SP, LaRocca A, McGoldrick MT, Mercado Y, Pham P, Schwartz JE, Seid H, Thomas SJ, Shimbo D. Psychological Stress and the Diurnal Patterns of Sodium Excretion and Blood Pressure: Results From the SABRE Study. J Am Heart Assoc. 2026 Oct 16:e050471. doi: 10.1161/JAHA.126.050471. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daichi Shimbo, MD principal investigator
Professor of Medicine, Dept of Med Beh Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Stress Intervention in people with Blood Pressure and Psychological Stress, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) (time frame: Over 24-hour ambulatory period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.