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

NCT02315859 | Completed

• 1 other identifier: 089/14
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure

Keywords

suction work

Outcome Measures

Primary Outcomes (1)

• Composite outcome measure: absolute suction work using MAPSE (Mitral annular plane systolic excursion) and IVPG (Intraventricular pressure gradients)

  During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up.

Secondary Outcomes (4)

• Composite outcome measure: absolute suction work using MAPSE and catheter-derived invasive pressure

  During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up.

• Composite outcome measure: absolute suction work using impedance catheter-derived volumes and IVPG

  During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up.

• Absolute suction work using tissue velocities (e'/s')

  During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up.

• Absolute suction work using tissue velocities (s'/L0, L0 = end-systolic ventricular length)

  During the cardiac catheterization: at rest, under Dobutamin 20ug/kg, under Dobutamin 40ug/kg (expected average duration of 20 minutes); no follow-up.

Study Arms (1)

All patients

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients referred to emergency coronary intervention
• \. 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel: collaborator

Study Sites (1)

Departement of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Christian Seiler, Prof

  STUDY CHAIR

• Stefano de Marchi, MD

  Departement of Cardiology, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 12, 2014
• Study Start: December 31, 2014
• Primary Completion: December 31, 2016
• Study Completion: June 30, 2017
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CH (1)