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The Broken Heart Study II (BHS-II)

Study acronym: BHS
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Results posted: Sep 29, 2026 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 3 to 2
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Feb 28, 2025 to Nov 11, 2025
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Feb 2026 to Feb 28, 2026
    v9
  3. Trial status: Recruiting to Active, Not Recruitingv8 Show 4 more changesShow less
    • Enrollment target: estimated 106 to confirmed 66
    • Primary completion date changed from estimate of Nov 30, 2024 to Feb 28, 2025
    • Study completion date: Dec 31, 2024 to Feb 2026
    • Site details revised
  4. Re-verified, no change to tracked fieldsv7
  5. Enrollment target: 246 to 106
    • Secondary endpoints: 4 to 3
    • Study description revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Aug 31, 2024 to Nov 30, 2024
    • Study completion date: Sep 30, 2024 to Dec 31, 2024
    • Start date: Sep 1, 2020 to Sep 2, 2020
    • Eligibility criteria expanded, about 18 words
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  3. Start date: Jul 15, 2020 to Sep 1, 2020v3
  4. Start date: Jun 1, 2020 to Jul 15, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 triggering events and mental stress responsiveness to 1-year prognosis after TS event.
Trial Details
NCT Number NCT04325321
Lead Sponsor The Miriam Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Takotsubo Cardiomyopathy
Related terms Takotsubo Cardiomyopathy
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov