NCT03636490: SABRE

Stress, Salt Excretion, and Nighttime Blood Pressure

Completed NA Results posted Last updated 11 May 2025

What this trial tests

NA trial testing Psychological Stress Intervention in Blood Pressure in 323 participants. Completed in 4 December 2023.

Timeline

16 November 2018

Primary endpoint
4 December 2023

4 December 2023

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	323
Start date	16 November 2018
Primary completion	4 December 2023
Estimated completion	4 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Psychological Stress Intervention

Conditions studied

• Blood Pressure — all drugs for Blood Pressure →
• Psychological Stress — all drugs for Psychological Stress →

Sponsor

Columbia University

Who can join

21 and older, any sex, with Blood Pressure or Psychological Stress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) Primary · Over 24-hour ambulatory period

Group	Value	95% CI
Psychological Stress	1.4	± 1.3

Systolic Blood Pressure Dipping (Aim 2) Primary · Over 24-hour ambulatory period

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).

Group	Value	95% CI
Psychological Stress	14.3	± 6.0

Mean Perceived Stress Level Secondary · Over 24-hour ambulatory period

This is to measure the ecological stress level for the awake period during which the participants' sodium excretion is monitored. A 10-point Visual Analog Scale (VAS) (0=Not at all, 5=Moderately, and 10=Extremely) was used to assess stress.

Group	Value	95% CI
Psychological Stress	1.5	± 1.5

24-hour Sodium Excretion Secondary · Over 24-hour ambulatory period

Rate of sodium excretion, measured from urine collected from participants during the ambulatory period.

Group	Value	95% CI
Psychological Stress	121.8	± 51.4

24-hour Potassium Excretion Secondary · Over 24-hour ambulatory period

Rate of potassium excretion, measured from urine collected from participants during the ambulatory period.

Group	Value	95% CI
Psychological Stress	53.7	± 22.8

24-hour Creatinine Clearance Secondary · Over 24-hour ambulatory period

Rate of creatine clearance, measured from urine collected from participants during the ambulatory period.

Group	Value	95% CI
Psychological Stress	112.7	± 34.0

Fractional Excretion of Sodium Secondary · Over 24-hour ambulatory period

Fractional excretion of sodium is the amount of sodium that leaves the body through urine compared to the amount filtered and reabsorbed by the kidney.

Group	Value	95% CI
Psychological Stress	0.5	± 0.2

EMA Stress Secondary · Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported stress through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse stress. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Group	Value	95% CI
Psychological Stress	1.5	± 1.5

EMA Anger Secondary · Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported anger through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse anger. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Group	Value	95% CI
Psychological Stress	0.5	± 1.1

EMA Aggravation Secondary · Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported aggravation/irritation through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse aggravation. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Group	Value	95% CI
Psychological Stress	0.8	± 1.2

EMA Anxiety Secondary · Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported anxiety through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse anxiety. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Group	Value	95% CI
Psychological Stress	1.2	± 1.4

EMA Depressed Secondary · Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported sadness/depression through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse depression. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Group	Value	95% CI
Psychological Stress	0.6	± 1.2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The stress, salt excretion, and nighttime blood pressure (SABRE) study: Rationale and study design.
   Dong M, McGoldrick MT, Seid H, Cohen LP, et al · · 2022 · cited 1× · PMID 38560071 · DOI 10.1016/j.ahjo.2022.100099