The Broken Heart Study II (BHS-II)

NCT04325321 | Completed DMC

• 1 other identifier: R01HL149672
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are as follows:

1. 1.To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS).
2. 2.To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event.

Conditions

Takotsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Mean change (in pg/mL) in plasma epinephrine levels

  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.

  Up to 4 weeks

• Mean change (in pg/mL) in plasma norepinephrine levels

  Blood samples for plasma norepinephrine 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 norepinephrine levels.

  Up to 4 weeks

Secondary Outcomes (3)

• Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square)

  Up to 4 weeks

• Left ventricular ejection fraction (%)

  12 months

• Average Global Longitudinal Strain (GLS)

  12 months

Other Outcomes (1)

• Proportion of patients with major adverse cardiac and cerebrovascular events

  12 months

Study Arms (1)

Stress reactivity

OTHER

Stress reactivity test

Other: Stress reactivity test

Interventions

Stress reactivity test OTHER

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.

Stress reactivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18
• A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
• Ability to understand and speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• Salmoirago-Blotcher E, Keirns NG, Ouaddi S, Tripolone J, Liu C, Breault C, Dettmer A. Chronic adrenocortical activity and onset of Takotsubo syndrome. Eur J Cardiovasc Nurs. 2026 Jan 21:zvag023. doi: 10.1093/eurjcn/zvag023. Online ahead of print.

  PMID: 41562264 DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Elena Salmoirago-Blotcher, MD, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist, Associated Professor of Medicine

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 27, 2020
• Study Start: September 2, 2020
• Primary Completion: November 11, 2025
• Study Completion: February 28, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified research data will be made available once the main findings from the final research data set have been accepted for publication.
• Access Criteria: Researchers interested in obtaining the de-identified data and associated documentation (e.g. codebook) can make a request to the principal investigator. requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, and 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or Statistical Package for the Social Sciences (SPSS) file formats.

Locations

US (1)