Stress, Salt Excretion, and Nighttime Blood Pressure

Blood Pressure Clinical Trial

— SABRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03636490
• Other study ID #: AAAS0154
• Secondary ID: 1R01HL137818-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: June 30, 2024
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Psychological Stress Intervention
Participant will be shown a series of words for five minutes and a research coordinator will ask him/her to name the color of each (Stroop Color-Word Conflict Task). Then, for another five minutes, the participant will be asked to count backwards out loud by sevens starting from 1,000 (Mental Arithmetic Task). The research assistant will ask the participant to work as quickly and accurately as possible for both tasks.

Locations

Country	Name	City	State
United States	Columbia University Medical Center - Shimbo Hypertension Lab	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary sodium excretion rate with stress	This is to measure urinary sodium excretion after provoked psychological stress.	For 3 hours during the Laboratory Visit.
Primary	Awake-to-sleep ratio of urinary excretion rate	This is to examine the diurnal pattern of sodium excretion in a naturalistic environment.	For 24 hours following the Laboratory Visit.
Primary	Systolic blood pressure dipping at night	This is to examine the diurnal pattern of Blood Pressure in a naturalistic environment.	For 24 hours following the Laboratory Visit.
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.	Up to 24 hours following Laboratory Visit.