Stress, Salt Excretion, and Nighttime Blood Pressure

NCT03636490 | Completed Results

• 2 other identifiers: AAAS01541R01HL137818-01A1
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Psychological Stress

Keywords

Non-Dipping Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)

  Over 24-hour ambulatory period

• Systolic Blood Pressure Dipping (Aim 2)

  Systolic blood pressure (SBP) dipping refers to the normal physiological decline in SBP during nighttime sleep. SBP dipping (%) was calculated as 100 \* (mean awake SBP - mean asleep SBP) / (mean awake SBP).

  Over 24-hour ambulatory period

Secondary Outcomes (10)

• Mean Perceived Stress Level

  Over 24-hour ambulatory period

• 24-hour Sodium Excretion

  Over 24-hour ambulatory period

• 24-hour Potassium Excretion

  Over 24-hour ambulatory period

• 24-hour Creatinine Clearance

  Over 24-hour ambulatory period

• Fractional Excretion of Sodium

  Over 24-hour ambulatory period

Other Outcomes (3)

• Change in Urinary Sodium Excretion Rate With Stress

  Over 24-hour ambulatory period

• Systolic Blood Pressure Dipping

  Over 24-hour ambulatory period

• Diastolic Blood Pressure Dipping

  Over 24-hour ambulatory period

Study Arms (1)

Psychological Stress

EXPERIMENTAL

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.

Behavioral: Psychological Stress Intervention

Interventions

Psychological Stress Intervention 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.

Also known as: Provoked Psychological Stress

Psychological Stress

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years or older
• Screening mean blood pressure less than or equal to 160/105 mm Hg

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Medical Center - Shimbo Hypertension Lab

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Daichi Shimbo
• Organization: Columbia University Irving Medical Center

ds2231@cumc.columbia.edu

‭(646) 317-0305‬

Study Officials

• Daichi Shimbo, MD

  Professor of Medicine, Dept of Med Beh Cardiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will receive the same intervention. All associated groups will be aware of the intervention protocol and the single-arm study model.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Dept of Med

Model Details: All participants will be receive the same intervention.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 17, 2018
• Study Start: November 16, 2018
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)