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OCTOPUS: Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Sponsor
University of Luebeck (Other)
Overall Status
Recruiting
CT.gov ID
NCT03726528
Collaborator
(none)
25
Enrollment
1
Location
63
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: Measurements of left ventricular pressure and volume
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
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 :
Sep 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Changes in contractility derived from pressure-volume measurements [Day 0]

    systolic/diastolic pressure-volume relationship (mmHg/ml)

  2. Changes in contractility derived from pressure-volume measurements [Day 0]

    peak-power index (mmHG/s)

  3. Changes in contractility derived from pressure-volume measurements [Day 0]

    peak filling rate (ml/s)

  4. Changes in contractility derived from pressure-volume measurements [Day 0]

    stroke work (mmHG x ml)

  5. Changes in contractility derived from pressure-volume measurements [Day 0]

    relaxation constant "Tau" (ms)

  6. Changes in contractility derived from pressure-volume measurements [Day 0]

    time to Emax (ms)

  7. Changes in contractility derived from pressure-volume measurements [Day 0]

    max/min rate of left ventricular pressure change (mmHg/s)

Secondary Outcome Measures

  1. Energetic parameters derived from pressure-volume measurements [Day 0]

    stroke work, potential energy (mmHg x ml)

  2. Energetic parameters derived from pressure-volume measurements [Day 0]

    total pressure volume area (mmHg/ml)

  3. Afterload parameters derived from pressure-volume measurements [Day 0]

    arterial elastance (mmHg/ml)

  4. Afterload parameters derived from pressure-volume measurements [Day 0]

    ventricular arterial coupling (no dimension)

  5. Afterload parameters derived from pressure-volume measurements [Day 0]

    total arterial compliance (mmHg/ml)

  6. - Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging [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 [Day 0]

    (troponin, NT-proBNP)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical clinic II-UKSH Luebeck Schleswig-Holstein Germany 23562

Sponsors and Collaborators

  • University of Luebeck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. med. Ingo Eitel, MD, Director, University of Luebeck
ClinicalTrials.gov Identifier:
NCT03726528
Other Study ID Numbers:
  • 17-078
First Posted:
Oct 31, 2018
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Takotsubo Cardiomyopathy
Syndrome

Study Results

No Results Posted as of May 12, 2021