Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up epoch recorded immediately before 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 belowSelect...
I am a woman aged 44-55 and am in the late stage of transitioning to menopause.
DASHH Trial 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.
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 moreSecondary 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
~300
Find a Location
Who is running the clinical trial?
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
University of North Carolina, Chapel HillLead Sponsor
1,521 Previous Clinical Trials
4,196,600 Total Patients Enrolled
55 Trials studying Depression
34,582 Patients Enrolled for Depression
Margo Nathan, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking or have recently taken medications that affect my RAAS.I have taken blood pressure medication in the last 3 months.You currently have a problem with drinking alcohol or using drugs.If you are in the perimenopausal depression group, you are currently experiencing very severe depressive symptoms based on a specific test.I have a history of bipolar or psychotic disorders, or depression if not in the perimenopausal group.You have taken antihistamines in the last two weeks.I have a heart condition, diabetes, or another serious health issue.I am a woman aged 44-55 and am in the late stage of transitioning to menopause.I have thought about suicide recently and attempted it within the last 2 years.I have taken antihistamines in the last two weeks.I have used steroids in the past 3 months.I have used hormonal treatments like HRT or birth control pills in the last 30 days.My antidepressant dose has been stable for the last 30 days.I have used steroids in the past 3 months.You currently smoke cigarettes or use nicotine products.I am not taking any medications that affect the RAAS, as per the study team's list.
Research Study Groups:
This trial has the following groups:- Group 1: Women with perimenopausal depression
- Group 2: Women without perimenopausal depression
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05570721 — N/A
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger