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Completed

NCT Number: NCT02408003

Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.

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.

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Key information

Conditions

Heart Failure, Diastolic Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Failure Heart Murmurs Heart Valve Diseases Monitoring, Physiologic Pathological Conditions, Signs and Symptoms Physiology Signs and Symptoms Sprains and Strains Systolic Murmurs Ventricular Outflow Obstruction Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thoraxoperation/TIVA, Sahlgrenska universitetssjukhuset

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Levosimendan

Drug

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.

Other names: Daxim, Simdax

Milrinone

Drug

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.

Other names: Primacor, Corotrop, Milicor

Primary outcomes

  1. Change in diastolic strain rate

    Time frame: After each physiologic intervention, and at 30 and 60 min after start of iv infusion of drug.

    Diastolic strain rate defined as peak E wave strain rate as measured by 2D speckle tracking of the left ventricular wall.

Secondary outcomes

  1. Change in systolic strain and strain rate

    Time frame: After each physiologic intervention, and at 30 and 60 min after start of iv infusion of drug.

    Systolic strain and strain rate defined as their respective peak values during systole, measured by 2D speckle tracking of the left ventricular wall.

  2. Change in cardiac output

    Time frame: After each physiologic intervention, and at 30 and 60 min after start of iv infusion of drug.

    Measured through pulmonary artery thermodilution as liters per minute. A baseline measurement is done before infusion is started.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 3, 2015
Registry last updated
May 9, 2017

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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