Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.

NCT02408003 | Completed

• 1 other identifier: Fredholm strain study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transesophageal; Echocardiography; Milrinone; Levosimendan; Strain; Deformation; Diastole; Afterload; Preload; Systole

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in systolic strain and strain rate

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

• Change in cardiac output

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

Study Arms (2)

Levosimendan

EXPERIMENTAL

1. st dose: 12 µg/kg iv bolus for 10 min followed by 0,1 µg/kg/min for 20 min. 2. nd dose: 12 µg/kg iv bolus for 10 min followed by 0,2 µg/kg/min for 20 min.

Drug: Levosimendan

Milrinone

EXPERIMENTAL

1. st dose: 48 µg/kg iv bolus for 10 min followed by 0,4 µg/kg/min for 20 min. 2. nd dose: 48 µg/kg iv bolus for 10 min followed by 0,8 µg/kg/min for 20 min.

Drug: Milrinone

Interventions

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.

Also known as: Daxim, Simdax

Levosimendan

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.

Also known as: Primacor, Corotrop, Milicor

Milrinone

Eligibility Criteria

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

You may qualify if:

• Subject has aortic valve stenosis
• Subject is scheduled for open heart aortic valve replacement with or without simultaneous coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Thoraxoperation/TIVA, Sahlgrenska universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Aortic Valve Stenosis; Sprains and Strains; Heart Murmurs; Systolic Murmurs

Interventions

Simendan; Milrinone

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amrinone; Aminopyridines; Amines; Pyridines

Study Officials

• Sven-Erik Ricksten, Professor

  Dept of Anesthesia and Intensive Care, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)