Brief Title
Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.
Official Title
What Are the Changes in Cardiac Deformation Variables and Hemodynamic Parameters Following Changes in Cardiac Loading Conditions and After Administration of Two Different Inotropic Drugs.
Brief Summary
The investigators want to compare the effects of two drugs, levosimendan and milrinone, on
cardiac muscle, both in terms of contractility and relaxation. Half of the participants will
be randomized to each drug. The effects will be measured through echocardiographic
deformation analyses.
Since deformation analyses could be dependent on different loading conditions of the heart, a
second purpose of the study is to investigate the changes on deformation parameters after
applied changes in preload and afterload, but also heart rate.
Detailed Description
Aortic stenosis is associated with myocardial hypertrophy and diastolic dysfunction. In
patients undergoing open aortic valve replacement surgery due to stenosis, the investigators
want to compare the effect on myocardial relaxation between two commonly used drugs,
levosimendan and milrinone, using catheter-based measurements in combination with
echocardiographic evaluation.
Standard anaesthesia and surgical care for these patients is performed. After surgery is
completed and the participant is transferred to the intensive care unit, the studies are
performed during general anaesthesia and the participants still connected to a respirator
with controlled ventilation.
Echocardiographic data will be collected simultaneously with hemodynamic parameters - first
at two control measurements, then after each of two different doses of the drug. Preload,
afterload and heart rate will be kept stable during this intervention. The echocardiographic
data is later analyzed offline for strain and strain rate.
To further investigate the dependency of strain and strain rate on changes in preload,
afterload, and heart rate, these variables are consecutively changed prior to drug
administration. For this purpose, all patients first have their baseline data recorded,
thereafter are paced at two different rates, then preload and afterload is altered by passive
leg elevation and phenylephrine, respectively. Hemodynamic and echocardiographic data are
collected simultaneously at baseline and after each intervention. Before administration of
the drugs, baseline conditions are restored.
Study Type
Interventional
Primary Outcome
Change in diastolic strain rate
Secondary Outcome
Change in systolic strain and strain rate
Condition
Heart Failure, Diastolic
Intervention
Levosimendan
Study Arms / Comparison Groups
Levosimendan
Description: st dose: 12 µg/kg iv bolus for 10 min followed by 0,1 µg/kg/min for 20 min. nd dose: 12 µg/kg iv bolus for 10 min followed by 0,2 µg/kg/min for 20 min.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
March 2014
Completion Date
May 2017
Primary Completion Date
May 2016
Eligibility Criteria
Inclusion Criteria:
- Subject has aortic valve stenosis
- Subject is scheduled for open heart aortic valve replacement with or without
simultaneous coronary artery bypass grafting
Exclusion Criteria:
- Less than normal systolic function, defined as ejection fraction less than 0,5
- Non-sinus rhythm
- Any major surgical complication
- Problems understanding the informed consent
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sven-Erik Ricksten, Professor, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT02408003
Organization ID
Fredholm strain study
Responsible Party
Principal Investigator
Study Sponsor
Sahlgrenska University Hospital, Sweden
Study Sponsor
Sven-Erik Ricksten, Professor, Principal Investigator, Dept of Anesthesia and Intensive Care, University of Gothenburg
Verification Date
May 2017