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Trial record 5 of 15 for:    nhlbi | Recruiting, Not yet recruiting Studies | Cardiomyopathies | United States

The Broken Heart Study II (BHS-II) (BHS)

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ClinicalTrials.gov Identifier: NCT04325321
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : January 5, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Elena Salmoirago-Blotcher, The Miriam Hospital

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

Condition or disease Intervention/treatment Phase
Takotsubo Cardiomyopathy Other: Stress reactivity test Not Applicable

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 discharge, clinically stable patients will undergo an in-person comprehensive interview to identify the events proximal to the onset of TS symptoms, complete a battery of psychosocial questionnaires and undergo a validated laboratory stress protocol. Baseline and reactive changes in measures of autonomic nervous system activity (epinephrine and norepinephrine - primary outcome), and in the secondary outcomes of cardiac vagal control and left ventricular function (ejection fraction; regional and global longitudinal strain assessed with speckle tracking echocardiography) will be assessed. Echocardiographic evaluations will be repeated 12 months thereafter together with information on major adverse cerebrovascular events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Stress reactivity
Stress reactivity test
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.





Primary Outcome Measures :
  1. Mean change (in pg/mL) in plasma epinephrine levels [ Time Frame: Up to 4 weeks ]
    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.

  2. Mean change (in pg/mL) in plasma norepinephrine levels [ Time Frame: Up to 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square) [ Time Frame: Up to 4 weeks ]
    High frequency power heart rate variability (hf-HRV) will be determined by averaging high frequency values for 4-min segments within each phase (Baseline, Emotion Recall), and change will be calculated (Emotion Recall minus Baseline). Data will be collected using a Digital Holter ECG Recorder - 5 Lead, 2 Channel.

  2. Left ventricular ejection fraction (%) [ Time Frame: 12 months ]
    A trans-thoracic echocardiogram will be performed with computation of ejection fraction according to current guidelines.

  3. Average Global Longitudinal Strain (GLS) [ Time Frame: 12 months ]
    Global Longitudinal Strain (GLS) will be assessed using off-line analysis software (TomTec imaging systems). GLS will be calculated as the average left ventricular longitudinal strain across the segments obtained using apical two, three, and four-chamber views. Because myocardial contraction results in left ventricular shortening in systole, GLS is a negative value.


Other Outcome Measures:
  1. Proportion of patients with major adverse cardiac and cerebrovascular events [ Time Frame: 12 months ]
    Composite of death from any cause, recurrence of TS, stroke, transient ischemic attack, and myocardial infarction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325321


Contacts
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Contact: Elena Salmoirago-Blotcher, MD, PhD 401-793-8325 ext 38325 Elena_Salmoirago-Blotcher@brown.edu

Locations
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United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Elena Salmoirago-Blotcher, MD, PhD The Miriam Hospital
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Responsible Party: Elena Salmoirago-Blotcher, Senior Research Scientist, Associated Professor of Medicine, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT04325321    
Other Study ID Numbers: R01HL149672 ( U.S. NIH Grant/Contract )
R01HL149672 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data generated under the project will be shared as per National Institutes of Health (NIH) Grant Policy and Lifespan Institutional Review Board guidelines. De-identified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be de-identified to avoid linkages to individual research participants and will be free of variables that could lead to deductive disclosure of the identity of individual subjects.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction