Status:
ACTIVE_NOT_RECRUITING
The Broken Heart Study II (BHS-II)
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Takotsubo Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goals of this study are as follows: 1. To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS). 2. To rigorously test the contribution of TS trigg...
Detailed Description
Newly admitted patients with a validated diagnosis of Takotsubo Syndrome (TS; n=106) will be enrolled from 3 large medical centers in the Providence, Rhode Island area. Between 2 and 4 weeks after dis...
Eligibility Criteria
Inclusion
- Age \>=18
- A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
- Ability to understand and speak English
Exclusion
- Inability or unwillingness to give informed consent
- Severe cognitive impairment
- Uncontrolled hypertension
- Acute psychosis
- High suicidal risk
- Pregnancy
- Poor echocardiographic window
- Conditions that would interfere with adherence to study requirements (e.g., ongoing alcohol or substance abuse)
- If the participant is clinically unstable
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04325321
Start Date
September 2 2020
End Date
February 1 2026
Last Update
April 27 2025
Active Locations (1)
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1
The Miriam Hospital
Providence, Rhode Island, United States, 02906