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Stress Management for High Blood Pressure (SABRE Trial)
N/A
Waitlist Available
Led By Daichi Shimbo, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 21 years or older
Be older than 18 years old
Must not have
Non-English speaking
History of overt cardiovascular disease (coronary heart disease, stroke, peripheral arterial disease, heart failure, permanent or recurring arrhythmia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours following laboratory visit.
Awards & highlights
No Placebo-Only Group
Summary
This trial will examine how psychological stress affects sodium excretion and blood pressure.
Who is the study for?
This trial is for adults over 21 with high blood pressure (BP) not exceeding 160/105 mm Hg, who can speak English. It's not suitable for those on BP medications or with a history of major medical conditions like cancer, heart disease, stroke, or chronic inflammatory diseases.
What is being tested?
The study investigates how stress affects the body's handling of salt and its impact on BP patterns. It will explore if stress-related changes in salt excretion during the day are linked to abnormal BP rhythms at night.
What are the potential side effects?
Since this trial involves psychological stress interventions rather than medication, side effects may include temporary increases in stress levels or discomfort related to the intervention process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
Select...
I have a history of serious heart or blood vessel diseases.
Select...
I have had high blood pressure caused by another condition.
Select...
I have a history of a major medical condition like cancer or autoimmune disease.
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I am on medication that significantly affects my blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours following laboratory visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours following laboratory visit.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Awake-to-sleep ratio of urinary excretion rate
Change in urinary sodium excretion rate with stress
Systolic blood pressure dipping at night
Secondary study objectives
Mean perceived stress level
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psychological StressExperimental Treatment1 Intervention
All participants will undergo stress-inducing tasks (psychological stress intervention) using cognitive research tools.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychological Stress Intervention
2018
N/A
~330
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,926 Previous Clinical Trials
47,763,950 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,008 Total Patients Enrolled
Daichi Shimbo, MDPrincipal Investigator - Professor of Medicine, Dept of Med Beh Cardiology
New York Presbyterian Hospital-Columbia Presbyterian Center, Trustees of Columbia University in the City of New York
AlbaNew York Medical College (Medical School)
Mt Sinai School Of Medicine (Residency)
2 Previous Clinical Trials
320 Total Patients Enrolled
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