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Completed

NCT Number: NCT03636490

Stress, Salt Excretion, and Nighttime 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.

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.

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Key information

Conditions

Blood Pressure Behavior Behavioral Symptoms Psychological Stress Stress, Psychological

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center - Shimbo Hypertension Lab

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Provoked Psychological Stress

Primary outcomes

  1. Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)

    Time frame: Over 24-hour ambulatory period

  2. 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).

Secondary outcomes

  1. Mean Perceived Stress Level

    Time frame: 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.

  2. 24-hour Sodium Excretion

    Time frame: Over 24-hour ambulatory period

    Rate of sodium excretion, measured from urine collected from participants during the ambulatory period.

  3. 24-hour Potassium Excretion

    Time frame: Over 24-hour ambulatory period

    Rate of potassium excretion, measured from urine collected from participants during the ambulatory period.

  4. 24-hour Creatinine Clearance

    Time frame: Over 24-hour ambulatory period

    Rate of creatine clearance, measured from urine collected from participants during the ambulatory period.

  5. Fractional Excretion of Sodium

    Time frame: 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.

  6. EMA Stress

    Time frame: 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.

  7. EMA Anger

    Time frame: 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.

  8. EMA Aggravation

    Time frame: 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.

  9. EMA Anxiety

    Time frame: 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.

  10. EMA Depressed

    Time frame: 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.

Other outcomes

  1. Change in Urinary Sodium Excretion Rate With Stress

    Time frame: Over 24-hour ambulatory period

  2. Systolic Blood Pressure Dipping

    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).

  3. Diastolic Blood Pressure Dipping

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure

Acronym: SABRE

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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