Stress, Salt Excretion, and Nighttime Blood Pressure (SABRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03636490|
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : January 14, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Psychological Stress||Behavioral: Psychological Stress Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||211 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will be receive the same intervention.|
|Masking:||None (Open Label)|
|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.|
|Official Title:||Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure|
|Actual Study Start Date :||November 16, 2018|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
Experimental: Psychological Stress
All participants will undergo stress-inducing tasks (psychological stress intervention) using cognitive research tools.
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.
Other Name: Provoked Psychological Stress
- Change in urinary sodium excretion rate with stress [ Time Frame: For 3 hours during the Laboratory Visit. ]This is to measure urinary sodium excretion after provoked psychological stress.
- Awake-to-sleep ratio of urinary excretion rate [ Time Frame: For 24 hours following the Laboratory Visit. ]This is to examine the diurnal pattern of sodium excretion in a naturalistic environment.
- Systolic blood pressure dipping at night [ Time Frame: For 24 hours following the Laboratory Visit. ]This is to examine the diurnal pattern of Blood Pressure in a naturalistic environment.
- Mean perceived stress level [ Time Frame: Up to 24 hours following Laboratory Visit. ]This is to measure the ecological stress level for the awake period during which the participants' sodium excretion is monitored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636490
|Contact: Patrick Pham, BS||(917) email@example.com|
|United States, New York|
|Columbia University Medical Center - Shimbo Hypertension Lab||Recruiting|
|New York, New York, United States, 10032|
|Contact: Patrick Pham, BS 917-920-0174 firstname.lastname@example.org|
|Principal Investigator: Daichi Shimbo, MD|
|Principal Investigator:||Daichi Shimbo, MD||Associate Professor of Medicine, Dept of Med Beh Cardiology|