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Stress, Salt Excretion, and Nighttime Blood Pressure (SABRE)

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ClinicalTrials.gov Identifier: NCT03636490
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Daichi Shimbo, Columbia University

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.


Condition or disease Intervention/treatment Phase
Blood Pressure Psychological Stress Behavioral: Psychological Stress Intervention Not Applicable

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.


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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.
Primary Purpose: Other
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, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Dong, BA (917) 920-0165 md3759@cumc.columbia.edu
Contact: Patrick Pham, BS (917) 920-0174 pp2744@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center - Center for Behavioral Cardiovascular Health Recruiting
New York, New York, United States, 10032
Contact: Melissa Dong, BA    917-920-0165    md3759@cumc.columbia.edu   
Principal Investigator: Daichi Shimbo, MD         
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Daichi Shimbo, MD Associate Professor of Medicine, Dept of Med Beh Cardiology

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Responsible Party: Daichi Shimbo, Associate Professor of Medicine, Dept of Med Beh Cardiology, Columbia University
ClinicalTrials.gov Identifier: NCT03636490     History of Changes
Other Study ID Numbers: AAAS0154
1R01HL137818-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daichi Shimbo, Columbia University:
Non-Dipping Blood Pressure
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms