Stress, Salt Excretion, and Nighttime Blood Pressure

NCT ID: NCT03636490

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2023-12-04

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.

Conditions

Blood Pressure; Psychological Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Psychological Stress

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.

Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Group Type: EXPERIMENTAL

Psychological Stress Intervention

Intervention Type: 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.

Interventions

Psychological Stress Intervention

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Provoked Psychological Stress

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daichi Shimbo

Professor of Medicine, Dept of Med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daichi Shimbo, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Dept of Med Beh Cardiology

Locations

Columbia University Medical Center - Shimbo Hypertension Lab

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R01HL137818-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS0154

Identifier Type: -

Identifier Source: org_study_id