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Completed

NCT Number: NCT03726528

Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

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

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Key information

Conditions

Takotsubo Syndrome Cardiomyopathies Cardiovascular Diseases Heart Diseases Takotsubo Cardiomyopathy Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical clinic II-UKSH

Lübeck, Schleswig-Holstein, 23562, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurements of left ventricular pressure and volume

Diagnostic Test

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Acronym: OCTOPUS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2018
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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