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Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops (OCTOPUS)

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ClinicalTrials.gov Identifier: NCT03726528
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ingo Eitel, University of Luebeck

Brief Summary:
Aim of this prospective study is to assess the pathophysiology of Takotsubo Syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms

Condition or disease Intervention/treatment Phase
Takotsubo Syndrome Diagnostic Test: Measurements of left ventricular pressure and volume Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Measurements of left ventricular pressure and volume
    Patients with suspected Takotsubo syndrome (typical ballooning in left ventriculography without significant obstructive coronary artery disease that sufficiently explains the contraction abnormalities) will undergo continuous online measurements of left ventricular pressure and volume using conductance catheters. Cardiac magnetic resonance (CMR) imaging will be performed in patients without contraindications for optimized morphological characterization and exclusion of important differential diagnoses.


Primary Outcome Measures :
  1. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    systolic/diastolic pressure-volume relationship (mmHg/ml)

  2. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    peak-power index (mmHG/s)

  3. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    peak filling rate (ml/s)

  4. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    stroke work (mmHG x ml)

  5. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    relaxation constant "Tau" (ms)

  6. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    time to Emax (ms)

  7. Changes in contractility derived from pressure-volume measurements [ Time Frame: Day 0 ]
    max/min rate of left ventricular pressure change (mmHg/s)


Secondary Outcome Measures :
  1. Energetic parameters derived from pressure-volume measurements [ Time Frame: Day 0 ]
    stroke work, potential energy (mmHg x ml)

  2. Energetic parameters derived from pressure-volume measurements [ Time Frame: Day 0 ]
    total pressure volume area (mmHg/ml)

  3. Afterload parameters derived from pressure-volume measurements [ Time Frame: Day 0 ]
    arterial elastance (mmHg/ml)

  4. Afterload parameters derived from pressure-volume measurements [ Time Frame: Day 0 ]
    ventricular arterial coupling (no dimension)

  5. Afterload parameters derived from pressure-volume measurements [ Time Frame: Day 0 ]
    total arterial compliance (mmHg/ml)

  6. - Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging [ Time Frame: Day 3 ]
    (presence of myocardial edema or late gadolinium enhancement, native T1 time, myocardial strain assessed by CMR feature tracking)

  7. - Correlation of pressure-volume measurements with biomarker release [ Time Frame: Day 0 ]
    (troponin, NT-proBNP)



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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:

  • Confirmed Takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up
  • Sinus rhythm during invasive measurements
  • Age ≥18 years
  • Written informed consent

Exclusion Criteria:

  • Cardiogenic shock
  • Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
  • Pregnancy
  • Participation in another trial

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): NCT03726528


Contacts
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Contact: Ingo Eitel, MD +49 451 500 44501 ingo.eitel@uksh.de
Contact: Thomas Stiermaier, MD +49 451 500 44501 thomas.stiermaier@uksh.de

Locations
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Germany
Medical clinic II-UKSH Recruiting
Luebeck, Schleswig-Holstein, Germany, 23562
Contact: Ingo Eitel, MD    +49 451 500 44501    ingo.eitel@uksh.de   
Contact: Thomas Stiermaier, MD    +49 451 500 44501    thomas.stiermaier@uksh.de   
Sponsors and Collaborators
University of Luebeck

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Responsible Party: Prof. Dr. med. Ingo Eitel, MD, Director, University of Luebeck
ClinicalTrials.gov Identifier: NCT03726528     History of Changes
Other Study ID Numbers: 17-078
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Takotsubo Cardiomyopathy
Syndrome
Disease
Pathologic Processes
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases