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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL137818-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological Stress Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) | 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). | Over 24-hour ambulatory period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 24-hour ambulatory period |
| 24-hour Sodium Excretion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Sodium Excretion Rate With Stress | Over 24-hour ambulatory period | |
| Systolic Blood Pressure Dipping | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daichi Shimbo, MD | Professor of Medicine, Dept of Med Beh Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center - Shimbo Hypertension Lab | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Then 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Then 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) | Posted | Mean | Standard Deviation | Ratio of awake-to-asleep | Over 24-hour ambulatory period |
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For 3 days prior to the laboratory visit through the completion of the ambulatory period, up to 1 week.
Adverse events were assessed by direct observation during the lab session, and self-report during the ambulatory session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Then 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daichi Shimbo | Columbia University Irving Medical Center | (646) 317-0305 | ds2231@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 7, 2025 | Apr 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2025 | Apr 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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All participants will be receive the same intervention.
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All participants will receive the same intervention. All associated groups will be aware of the intervention protocol and the single-arm study model.
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Rate of sodium excretion, measured from urine collected from participants during the ambulatory period. |
| Over 24-hour ambulatory period |
| 24-hour Potassium Excretion | Rate of potassium excretion, measured from urine collected from participants during the ambulatory period. | Over 24-hour ambulatory period |
| 24-hour Creatinine Clearance | Rate of creatine clearance, measured from urine collected from participants during the ambulatory period. | 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. | 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. | 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. | 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. | 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. | 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. | Over 24-hour ambulatory period |
| Over 24-hour ambulatory period |
| Diastolic Blood Pressure Dipping | Diastolic blood pressure (DBP) dipping refers to the normal physiological decline in DBP during nighttime sleep. DBP dipping (%) was calculated as 100 * (mean awake DBP - mean asleep DBP) / (mean awake DBP). | Over 24-hour ambulatory period |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Current smoking | Count of Participants | Participants |
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| Alcohol use | Count of Participants | Participants |
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| Parental history of hypertension | Count of Participants | Participants |
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| Body mass index | Mean | Standard Deviation | kg/m2 |
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| Systolic blood pressure (baseline) | Mean | Standard Deviation | mm Hg |
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| Diastolic blood pressure (baseline) | Mean | Standard Deviation | mm Hg |
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| Glucose | Mean | Standard Deviation | mg/dL |
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| Primary | 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). | Of the 182 participants, 175 had complete data on ratio of awake-to-asleep urinary excretion rate and SBP dipping, and high-quality urine collection. | Posted | Mean | Standard Deviation | percent | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Over 24-hour ambulatory period |
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| Secondary | 24-hour Sodium Excretion | Rate of sodium excretion, measured from urine collected from participants during the ambulatory period. | Posted | Mean | Standard Deviation | mmol/24 hours | Over 24-hour ambulatory period |
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| Secondary | 24-hour Potassium Excretion | Rate of potassium excretion, measured from urine collected from participants during the ambulatory period. | Posted | Mean | Standard Deviation | mmol/24 hours | Over 24-hour ambulatory period |
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| Secondary | 24-hour Creatinine Clearance | Rate of creatine clearance, measured from urine collected from participants during the ambulatory period. | Posted | Mean | Standard Deviation | mL/min | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | percent | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Over 24-hour ambulatory period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Over 24-hour ambulatory period |
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| Other Pre-specified | Change in Urinary Sodium Excretion Rate With Stress | Posted | Mean | Standard Deviation | uEq/min | Over 24-hour ambulatory period |
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| Other Pre-specified | Systolic Blood Pressure Dipping | 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). | Posted | Mean | Standard Deviation | percent | Over 24-hour ambulatory period |
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| Other Pre-specified | Diastolic Blood Pressure Dipping | Diastolic blood pressure (DBP) dipping refers to the normal physiological decline in DBP during nighttime sleep. DBP dipping (%) was calculated as 100 * (mean awake DBP - mean asleep DBP) / (mean awake DBP). | Posted | Mean | Standard Deviation | percent | Over 24-hour ambulatory period |
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| 323 |
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