Blood Pressure, Psychological Stress
Conditions
Keywords
Non-Dipping Blood Pressure
Brief 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. 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.
Interventions
BEHAVIORALPsychological Stress Intervention
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
All participants will receive the same intervention. All associated groups will be aware of the intervention protocol and the single-arm study model.
Intervention model description
All participants will be receive the same intervention.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 21 years or older * Screening mean blood pressure less than or equal to 160/105 mm Hg
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure Dipping (Aim 2) | 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). |
| Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) | Over 24-hour ambulatory period | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Perceived Stress Level | Over 24-hour ambulatory period | 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. |
| 24-hour Sodium Excretion | Over 24-hour ambulatory period | Rate of sodium excretion, measured from urine collected from participants during the ambulatory period. |
| 24-hour Potassium Excretion | Over 24-hour ambulatory period | Rate of potassium excretion, measured from urine collected from participants during the ambulatory period. |
| 24-hour Creatinine Clearance | Over 24-hour ambulatory period | Rate of creatine clearance, measured from urine collected from participants during the ambulatory period. |
| EMA Aggravation | Over 24-hour ambulatory period | 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. |
| EMA Anger | Over 24-hour ambulatory period | 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. |
| EMA Anxiety | Over 24-hour ambulatory period | 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. |
| EMA Depressed | Over 24-hour ambulatory period | 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. |
| Fractional Excretion of Sodium | Over 24-hour ambulatory period | 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. |
| EMA Stress | Over 24-hour ambulatory period | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Sodium Excretion Rate With Stress | Over 24-hour ambulatory period | — |
| Systolic Blood Pressure Dipping | 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). |
| Diastolic Blood Pressure Dipping | Over 24-hour ambulatory period | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 182 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dropped out or incomplete data | 141 |
Baseline characteristics
| Characteristic | Psychological Stress |
|---|---|
| Age, Continuous | 32.4 Years STANDARD_DEVIATION 10.7 |
| Alcohol use Heavy | 3 Participants |
| Alcohol use Moderate | 108 Participants |
| Alcohol use None | 71 Participants |
| Body mass index | 24.3 kg/m2 STANDARD_DEVIATION 4.6 |
| Current smoking No | 177 Participants |
| Current smoking Yes | 5 Participants |
| Diastolic blood pressure (baseline) | 72.2 mm Hg STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Glucose | 89.1 mg/dL STANDARD_DEVIATION 7.1 |
| Parental history of hypertension No | 115 Participants |
| Parental history of hypertension Yes | 67 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 51 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 76 Participants |
| Sex/Gender, Customized Female | 113 Participants |
| Sex/Gender, Customized Male | 68 Participants |
| Sex/Gender, Customized Prefers not to identify | 1 Participants |
| Sex/Gender, Customized Unknown | 0 Participants |
| Systolic blood pressure (baseline) | 111.0 mm Hg STANDARD_DEVIATION 10.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 323 |
| other Total, other adverse events | 0 / 323 |
| serious Total, serious adverse events | 0 / 323 |
Outcome results
Primary
Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) | 1.4 Ratio of awake-to-asleep | Standard Deviation 1.3 |
p-value: 0.003295% CI: [0.0007, 0.0034]Regression, Linear
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).
Time frame: Over 24-hour ambulatory period
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Systolic Blood Pressure Dipping (Aim 2) | 14.3 percent | Standard Deviation 6 |
p-value: 0.03795% CI: [0.0487, 1.6]Regression, Linear
Secondary
24-hour Creatinine Clearance
Rate of creatine clearance, measured from urine collected from participants during the ambulatory period.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | 24-hour Creatinine Clearance | 112.7 mL/min | Standard Deviation 34 |
Secondary
24-hour Potassium Excretion
Rate of potassium excretion, measured from urine collected from participants during the ambulatory period.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | 24-hour Potassium Excretion | 53.7 mmol/24 hours | Standard Deviation 22.8 |
Secondary
24-hour Sodium Excretion
Rate of sodium excretion, measured from urine collected from participants during the ambulatory period.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | 24-hour Sodium Excretion | 121.8 mmol/24 hours | Standard Deviation 51.4 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | EMA Aggravation | 0.8 Score on a scale | Standard Deviation 1.2 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | EMA Anger | 0.5 Score on a scale | Standard Deviation 1.1 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | EMA Anxiety | 1.2 Score on a scale | Standard Deviation 1.4 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | EMA Depressed | 0.6 Score on a scale | Standard Deviation 1.2 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | EMA Stress | 1.5 Score on a scale | Standard Deviation 1.5 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Fractional Excretion of Sodium | 0.5 percent | Standard Deviation 0.2 |
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.
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Mean Perceived Stress Level | 1.5 score on a scale | Standard Deviation 1.5 |
Other Pre-specified
Change in Urinary Sodium Excretion Rate With Stress
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Change in Urinary Sodium Excretion Rate With Stress | 116.4 uEq/min | Standard Deviation 125.4 |
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).
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Diastolic Blood Pressure Dipping | 19.9 percent | Standard Deviation 7.9 |
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).
Time frame: Over 24-hour ambulatory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychological Stress | Systolic Blood Pressure Dipping | 13.9 percent | Standard Deviation 6.5 |