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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
Participants in either group may be on antidepressant medications (for any indication), but doses must be stable within 30 days of study participation
Timeline
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.
Awards & highlights

DASHH Trial 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.Check my eligibility
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.See study design
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.

DASHH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 44-55 and am in the late stage of transitioning to menopause.
Select...
My antidepressant dose has been stable for the last 30 days.

DASHH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately prior to the stress task.
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to the stress task. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in plasma aldosterone (pg/mL) levels in response to the stress task.
Change in plasma angiotensin II (pg/mL) levels in response to the stress task.
Change in plasma renin (pg/mL/hr) levels in response to the stress task
+5 more
Secondary outcome measures
Heart rate
Heart rate

DASHH Trial Design

2Treatment groups
Experimental Treatment
Group I: Women without perimenopausal depressionExperimental Treatment1 Intervention
Participants will undergo a social stress task (TSST)
Group II: Women with perimenopausal depressionExperimental Treatment1 Intervention
Participants will undergo a social stress task (TSST)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trier Social Stress Test
2017
N/A
~290

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,186,688 Total Patients Enrolled
54 Trials studying Depression
33,668 Patients Enrolled for Depression
The Foundation of Hope for Research and Treatment of Mental IllnessUNKNOWN
1 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Depression
2 Patients Enrolled for Depression
Margo Nathan, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Women with perimenopausal depression Clinical Trial Eligibility Overview. Trial Name: NCT05570721 — N/A
Depression Research Study Groups: Women with perimenopausal depression, Women without perimenopausal depression
Depression Clinical Trial 2023: Women with perimenopausal depression Highlights & Side Effects. Trial Name: NCT05570721 — N/A
Women with perimenopausal depression 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570721 — N/A
Depression Patient Testimony for trial: Trial Name: NCT05570721 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom does this clinical trial extend its recruitment criteria?

"This research is recruiting 30 individuals aged 44-55 years that suffer from cardiovascular ailments. Specifically, we are looking for women in the late perimenopausal stage whose menstrual cycles have been absent for at least two months but no longer than one year prior to enrolment. Additionally, any antidepressant prescriptions must remain unchanged during a thirty day period before study commencement."

Answered by AI

Are there any enrolment opportunities for individuals in this research project?

"According to the information provided on clinicaltrials.gov, recruitment for this trial ceased after its first posting and subsequent editing on October 5th 2022. Nonetheless, 1739 other studies are still searching for participants at present."

Answered by AI

Is participation in this research open to individuals over the age of twenty?

"This clinical trial seeks patients aged 44 to 55, with 291 studies for minors and 1309 dedicated exclusively to seniors."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
2
What site did they apply to?
University of North Carolina at Chapel Hill

Why did patients apply to this trial?

Relief from MCI, depression and stress. I would like to try something out for menopausal please help.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do pre-screening take?
PatientReceived 2+ prior treatments
~8 spots leftby Oct 2024