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NCT04325321 · ClinicalTrials.gov registry record · NA

The Broken Heart Study II (BHS-II)

A NA study of Takotsubo Cardiomyopathy, sponsored by The Miriam Hospital.

Active
Registry status
NA
Development phase
66
Enrollment target
1
Study location

NCT04325321: Active NA study of Takotsubo Cardiomyopathy, sponsored by The Miriam Hospital.

NCT04325321 is a NA study of Takotsubo Cardiomyopathy that is active but no longer recruiting, run by The Miriam Hospital. The registered enrollment target is 66 participants, below the 508-participant average among 3 other Takotsubo Cardiomyopathy trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04325321, a NA study of Takotsubo Cardiomyopathy, is active but no longer recruiting, sponsored by The Miriam Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
66 participants
Enrollment target
1
Study location

Study 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 triggering events and mental stress responsiveness to 1-year prognosis after TS event.

Primary Outcome

Blood samples for plasma epinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall levels.

Conditions Studied

Interventions

  • OTHER Stress reactivity test

Study Locations (1)

Rhode Island

  • The Miriam Hospital - Providence

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2020-09-02
Est. Completion 2026-02
Phase NA
The Miriam Hospital

136 total trials

What the registry record for NCT04325321 still lists

NCT04325321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 508-participant average among 3 other Takotsubo Cardiomyopathy trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Takotsubo Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention - of which Stress reactivity test is the first listed.

NCT04325321 reports a single indexed study location in Rhode Island.

Frequently Asked Questions

What is clinical trial NCT04325321 about?

NCT04325321 is a clinical study titled "The Broken Heart Study II (BHS-II)". 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.

What is the current status of trial NCT04325321?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 66 participants. The study started on 2020-09-02. Estimated completion is 2026-02.

What conditions does trial NCT04325321 study?

This clinical trial studies the following conditions: Takotsubo Cardiomyopathy.

What interventions are being tested in trial NCT04325321?

The interventions under investigation include: Stress reactivity test (OTHER).

Who is sponsoring clinical trial NCT04325321?

This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04325321 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04325321, the US trial registry maintained by the National Library of Medicine. NCT04325321 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.