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The Broken Heart Study II (BHS-II)

NCT04325321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Takotsubo Cardiomyopathy

Interventions

OTHER

Stress reactivity test

The protocol consists of Resting Baseline (BL), Emotion Recall (ER), followed by a Recovery Phase (RP). Heart rate and blood pressure are measured at baseline and then every 5 minutes during ER and RP. Resting Baseline (BL - 10 min). The participant is instructed to rest quietly. Emotion Recall (ER - 5-10 min). The participant is instructed to think about the incident associated with the onset of their cardiac event and bring to mind details of the incident. When the participants have the incident clearly in mind, they are instructed to relate the incident and their experience out loud; frequent questions to re-elicit the emotion are asked. Recovery Phase (RP - 20 min). Upon completion of RP, the catheter is removed and participants are de-instrumented. Blood samples for plasma catecholamines, assessments of heart rate variability, and echocardiograms are performed 10-min into BL, 10-min into ER, and 18 minutes into RP.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Elena Salmoirago-Blotcher, MD, PhD · The Miriam Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2025-11-11
Completion
2026-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325321 on ClinicalTrials.gov