Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.

Aortic Valve Stenosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408003
• Other study ID #: Fredholm strain study
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: May 8, 2017
• Start date: March 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Failure
• Heart Failure, Diastolic
• Monitoring, Physiologic
• Physiology

Intervention

Drug:
• Levosimendan
Data is collected at baseline as two controls. Three physiological interventions follows, and data is collected after each: Increasing heart rate in two steps by atrial pacing through a temporary pacemaker. Raising cardiac preload by increasing central venous pressure through leg elevation. Raising cardiac afterload by increasing systemic vascular resistance through administering of phenylephrine. Baseline is restored, and data is collected before drug adminstration as two controls, then after a first (half) dose, and finally after a second (full) dose.
• Milrinone
Data is collected at baseline as two controls. Three physiological interventions follows, and data is collected after each: Increasing heart rate in two steps by atrial pacing through a temporary pacemaker. Raising cardiac preload by increasing central venous pressure through leg elevation. Raising cardiac afterload by increasing systemic vascular resistance through administering of phenylephrine. Baseline is restored, and data is collected before drug adminstration as two controls, then after a first (half) dose, and finally after a second (full) dose.

Locations

Country	Name	City	State
Sweden	Thoraxoperation/TIVA, Sahlgrenska universitetssjukhuset	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diastolic strain rate	Diastolic strain rate defined as peak E wave strain rate as measured by 2D speckle tracking of the left ventricular wall.	After each physiologic intervention, and at 30 and 60 min after start of iv infusion of drug.
Secondary	Change in systolic strain and strain rate	Systolic strain and strain rate defined as their respective peak values during systole, measured by 2D speckle tracking of the left ventricular wall.	After each physiologic intervention, and at 30 and 60 min after start of iv infusion of drug.
Secondary	Change in cardiac output	Measured through pulmonary artery thermodilution as liters per minute. A baseline measurement is done before infusion is started.	After each physiologic intervention, and at 30 and 60 min after start of iv infusion of drug.