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Exploratory measurement of the physiological effects, induced through changes in afterload, of left ventricular strain-volume loop


- candidate number27105
- NTR NumberNTR6349
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-apr-2017
- Secondary IDs2017-3166 
- Public TitleExploratory measurement of the physiological effects, induced through changes in afterload, of left ventricular strain-volume loop
- Scientific TitleExploratory measurement of the physiological effects, induced through changes in afterload, of left ventricular strain-volume loop
- ACRONYMStrain-volume loop after physiological changes in afterload
- hypothesisObjective: The overall aim of this project is to asses the characteristic changes of the strain-volume loop, after acute, physiological-induced, changes in afterload. We hypothesize that the strain-volume loop will present a leftward shift in case of a reduced afterload and a rightward shift in case of an increase afterload.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria- Age between 18 and 30 or above 60
- Male gender
- Mentally competent
- Exclusion criteria- History of cardiovascular diseases
- Diabetes Mellitus
- Use of medication or other substances which influences the cardiovascular system
- Contraindications for the usage of sublingual nitroglycerin
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate31-dec-2017
- Target number of participants40
- InterventionsTo induce the changes in afterload we will use two different interventions:
To reduce the afterload (and preload) we will use vasodilative medication (vasodilator; nitroglycerine), which will primary reduce the peripheral vascular resistance. To increase the afterload we will use anti gravity jeans to occlude the blood supply of the legs for 2 minutes (transient atrial occlusion), which will cause a increase in the peripheral vascular resistance.
- Primary outcomeThe primary study parameter will be the slope of the systolic strain-volume relation (Sslope)
- Secondary outcomeThe secondary parameters will be the early systolic strain (ԑ_ES), peak strain (peak ԑ) and the dissociation between the systolic and diastolic strain-volume relation during early diastole (UNCOUP_ED) and late diastole (UNCOUP_LD).
- Timepointsna
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. Hugo Hulshof
- CONTACT for SCIENTIFIC QUERIESMSc Hugo Hulshof
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryRecent technical developments allow monitoring of strain and volume using echocardiography. Using this information enables the production of an strain-volume loop. In this study we will investigate the relationship strain and volume in healthy controls before and after acute physiological-induced changes in afterload.
- Main changes (audit trail)
- RECORD18-apr-2017 - 1-jun-2017


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