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Stress Testing for Heart Disease (DASHH Trial)

N/A

Recruiting

Led By Margo Nathan, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women ages 44-55 in the late perimenopause reproductive phase. Perimenopausal status will be determined based on menstrual cycle history. We will enroll women who have had an interval of amenorrhea of at least 60 days but <1 year consistent with the late menopause transition

Be between 18 and 65 years old

Must not have

History of bipolar diagnosis or primary psychotic disorder for both groups; prior history of depression in the no-perimenopausal depression group

Current suicidal ideation with intent and history of suicide attempt within 2 years of study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up epoch recorded immediately before the stress task.

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore whether two stress pathways may be linked to an increased risk for cardiovascular disease in menopausal women.

Who is the study for?

This study is for women aged 44-55 in late perimenopause, who may be on stable antidepressant medication. It's not for those with severe depression, current CVD or diabetes, recent use of certain blood pressure or steroid medications, active smoking or substance abuse, or hormonal treatments within the last month.

What is being tested?

The trial explores how stress affects heart health and depression during menopause by testing responses to the Trier Social Stress Test. It aims to understand if disruptions in stress pathways contribute to cardiovascular disease risk in midlife women.

What are the potential side effects?

Since this trial involves a psychological stress test rather than medication, side effects are minimal but can include temporary increases in stress levels and related physiological responses such as increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 44-55 and am in the late stage of transitioning to menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of bipolar or psychotic disorders, or depression if not in the perimenopausal group.

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I have thought about suicide recently and attempted it within the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ epochs recorded immediately before the stress task and intervals of 0, 10, and 20 minutes after the stress task.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~epochs recorded immediately before the stress task and intervals of 0, 10, and 20 minutes after the stress task.

This trial's timeline: 3 weeks for screening, Varies for treatment, and epochs recorded immediately before the stress task and intervals of 0, 10, and 20 minutes after the stress task. for reporting.