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Stress Reactivity Test for Takotsubo Syndrome (BHS Trial)

N/A
Recruiting
Led By Elena Salmoirago-Blotcher, MD, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
Age >=18
Must not have
Severe cognitive impairment
Uncontrolled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at Takotsubo Syndrome, a condition where the heart doesn't pump blood as well as it should. They want to see if stress plays a role in how well patients do after having this condition.

Who is the study for?
The Broken Heart Study II is for adults over 18 with a new diagnosis of Takotsubo Syndrome, who can understand and speak English. It's not suitable for those unable to consent, with severe cognitive issues, uncontrolled high blood pressure, acute psychosis, high suicide risk, pregnancy or poor heart imaging quality.
What is being tested?
This study investigates the underlying causes of Takotsubo Syndrome (a stress-induced cardiomyopathy) and how stress events affect patients' health one year after diagnosis. Participants will undergo a stress reactivity test as part of the research.
What are the potential side effects?
Since this trial involves a stress reactivity test rather than medication or invasive procedures, side effects may include temporary emotional distress or anxiety due to induced psychological stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with takotsubo syndrome.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant memory or thinking problems.
Select...
My blood pressure is not well-controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change (in pg/mL) in plasma epinephrine levels
Mean change (in pg/mL) in plasma norepinephrine levels
Secondary study objectives
Average Global Longitudinal Strain (GLS)
Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square)
Left ventricular ejection fraction (%)
Other study objectives
Proportion of patients with major adverse cardiac and cerebrovascular events

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: Stress reactivityExperimental Treatment1 Intervention
Stress reactivity test

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,723 Total Patients Enrolled
The Miriam HospitalLead Sponsor
245 Previous Clinical Trials
37,792 Total Patients Enrolled
Elena Salmoirago-Blotcher, MD, PhDPrincipal Investigator - The Miriam Hospital
The Miriam Hospital
3 Previous Clinical Trials
259 Total Patients Enrolled

Media Library

Stress reactivity Clinical Trial Eligibility Overview. Trial Name: NCT04325321 — N/A
Takotsubo Syndrome Research Study Groups: Stress reactivity
Takotsubo Syndrome Clinical Trial 2023: Stress reactivity Highlights & Side Effects. Trial Name: NCT04325321 — N/A
Stress reactivity 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325321 — N/A
~20 spots leftby Dec 2025
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