N/A
N=323
Stress, Salt Excretion, and Nighttime Blood Pressure
Blood Pressure · Psychological Stress
Bottom Line
View on ClinicalTrials.gov: NCT03636490 ↗Enrolled (actual)
323
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) — 1.4 Ratio of awake-to-asleep — p=0.0032
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychological Stress Intervention (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1) |
1.4 | 0.0032 sig |
| PRIMARY Systolic Blood Pressure Dipping (Aim 2) |
14.3 | 0.037 sig |
| SECONDARY Mean Perceived Stress Level |
1.5 | — |
| SECONDARY 24-hour Sodium Excretion |
121.8 | — |
| SECONDARY 24-hour Potassium Excretion |
53.7 | — |
| SECONDARY 24-hour Creatinine Clearance |
112.7 | — |
| SECONDARY Fractional Excretion of Sodium |
0.5 | — |
| SECONDARY EMA Stress |
1.5 | — |
| SECONDARY EMA Anger |
0.5 | — |
| SECONDARY EMA Aggravation |
0.8 | — |
| SECONDARY EMA Anxiety |
1.2 | — |
| SECONDARY EMA Depressed |
0.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03636490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.