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Validation of New Non-Invasive Parameters of Diastolic Suction in the Left Ventricle

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ClinicalTrials.gov Identifier: NCT02315859
Recruitment Status : Unknown
Verified January 2016 by University Hospital Inselspital, Berne.
Recruitment status was:  Recruiting
First Posted : December 12, 2014
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Gottfried und Julia Bangerter-Rhyner-Stiftung
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

It is known that, at the end of the cardiac ejection period, potential energy is stored in elastic fibers of the heart, which promotes the suction of blood from the atria during early filling. The investigators have developed a new ultrasound-based method to quantify this suction effect. Here, it is necessary to reduce the complex 3-dimensional cardiac mechanics in a 1-dimensional (piston-like) pump system. In the study, several steps of model reduction will be tested. Each reduction is intended to allow non-invasive measurements to become increasingly simple and feasible at reduced echo quality. The reference method is the invasive data obtained from a pressure-volume conductance catheter. To increase the supply of potential energy in the elastic fibers, a substance (dobutamine) is administered for transient strengthening of the force of contraction.

Hypothesis: There is a good agreement between the new, non-invasive parameters and the invasive reference method for the quantification of the suction effect of the left ventricle, and the good correlation persists even with increasing model simplification.


Condition or disease
Diastolic Heart Failure

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of New Non-Invasive Parameters of Diastolic Suction in the Left Ventricle
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Group/Cohort
All patients
All patients



Primary Outcome Measures :
  1. Composite outcome measure: absolute suction work using MAPSE (Mitral annular plane systolic excursion) and IVPG (Intraventricular pressure gradients) [ Time Frame: During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up. ]

Secondary Outcome Measures :
  1. Composite outcome measure: absolute suction work using MAPSE and catheter-derived invasive pressure [ Time Frame: During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up. ]
  2. Composite outcome measure: absolute suction work using impedance catheter-derived volumes and IVPG [ Time Frame: During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up. ]
  3. Absolute suction work using tissue velocities (e'/s') [ Time Frame: During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up. ]
  4. Absolute suction work using tissue velocities (s'/L0, L0 = end-systolic ventricular length) [ Time Frame: During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Population with a large variety of clinical conditions leading to dyspnea (for example hypertensive or hypertrophic heart disease, dilated cardiomyopathy), and where no significant coronary artery disease or regional wall-motion abnormalities are identified.
Criteria

Inclusion Criteria:

  • 1. Patients referred to elective percutaneous coronary angiography
  • Stable cardio-pulmonary conditions
  • Sinus rhythm
  • Written informed consent to participate to the study

Exclusion Criteria

  • Patients referred to emergency coronary intervention
  • 2. Prior myocardial infarction, wall-motion-abnormalities, stenosis ≥50%
  • Prior cardiac surgery
  • More than mild left-sided valve disease
  • Documented pulmonary disease leading to dyspnea NYHA II or more, including history of asthma bronchiale
  • Any restrictive LV filling pattern without eccentric LV hypertrophy, such as in infiltrative myocardial diseases
  • Pericardial diseases, including prior pericardiotomy and pericardial effusions.
  • Pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT)
  • Known adverse reactions to Dobutamin or Esmolol
  • Women who are pregnant or breast feeding (β-HCG > 10 IU/L)

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): NCT02315859


Contacts
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Contact: Stefano de Marchi, MD +41316322111 stefano.demarchi@insel.ch

Locations
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Switzerland
Departement of Cardiology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Principal Investigator: Stefano de Marchi, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Gottfried und Julia Bangerter-Rhyner-Stiftung
Investigators
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Study Chair: Christian Seiler, Prof
Principal Investigator: Stefano de Marchi, MD Departement of Cardiology, Bern University Hospital

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02315859     History of Changes
Other Study ID Numbers: 089/14
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by University Hospital Inselspital, Berne:
suction work

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases