Stress, Salt Excretion, and Nighttime Blood Pressure (SABRE)
Primary Purpose
Blood Pressure, Psychological Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychological Stress Intervention
Sponsored by
About this trial
This is an interventional other trial for Blood Pressure focused on measuring Non-Dipping Blood Pressure
Eligibility 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
Sites / Locations
- Columbia University Medical Center - Shimbo Hypertension LabRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psychological Stress
Arm Description
All participants will undergo stress-inducing tasks (psychological stress intervention) using cognitive research tools.
Outcomes
Primary Outcome Measures
Change in urinary sodium excretion rate with stress
This is to measure urinary sodium excretion after provoked psychological stress.
Awake-to-sleep ratio of urinary excretion rate
This is to examine the diurnal pattern of sodium excretion in a naturalistic environment.
Systolic blood pressure dipping at night
This is to examine the diurnal pattern of Blood Pressure in a naturalistic environment.
Secondary Outcome Measures
Mean perceived stress level
This is to measure the ecological stress level for the awake period during which the participants' sodium excretion is monitored.
Full Information
NCT ID
NCT03636490
First Posted
August 9, 2018
Last Updated
January 12, 2022
Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03636490
Brief Title
Stress, Salt Excretion, and Nighttime Blood Pressure
Acronym
SABRE
Official Title
Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Psychological Stress
Keywords
Non-Dipping Blood Pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
211 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychological Stress
Arm Type
Experimental
Arm Description
All participants will undergo stress-inducing tasks (psychological stress intervention) using cognitive research tools.
Intervention Type
Behavioral
Intervention Name(s)
Psychological Stress Intervention
Other Intervention Name(s)
Provoked Psychological Stress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in urinary sodium excretion rate with stress
Description
This is to measure urinary sodium excretion after provoked psychological stress.
Time Frame
For 3 hours during the Laboratory Visit.
Title
Awake-to-sleep ratio of urinary excretion rate
Description
This is to examine the diurnal pattern of sodium excretion in a naturalistic environment.
Time Frame
For 24 hours following the Laboratory Visit.
Title
Systolic blood pressure dipping at night
Description
This is to examine the diurnal pattern of Blood Pressure in a naturalistic environment.
Time Frame
For 24 hours following the Laboratory Visit.
Secondary Outcome Measure Information:
Title
Mean perceived stress level
Description
This is to measure the ecological stress level for the awake period during which the participants' sodium excretion is monitored.
Time Frame
Up to 24 hours following Laboratory Visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Pham, BS
Phone
(917) 920-0174
Email
pp2744@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daichi Shimbo, MD
Organizational Affiliation
Associate Professor of Medicine, Dept of Med Beh Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center - Shimbo Hypertension Lab
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Pham, BS
Phone
917-920-0174
Email
pp2744@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Daichi Shimbo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Stress, Salt Excretion, and Nighttime Blood Pressure
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