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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03186339 -
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
|
||
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Terminated |
NCT02854319 -
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
|
N/A | |
Recruiting |
NCT05601453 -
The ReTAVI Prospective Observational Registry
|
||
Withdrawn |
NCT05481814 -
CPX in Paradoxical Low Flow Aortic Stenosis
|
||
Completed |
NCT02241109 -
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
|
N/A | |
Completed |
NCT01700439 -
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
|
N/A | |
Recruiting |
NCT04429035 -
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
|
N/A | |
Completed |
NCT04103931 -
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
|
N/A | |
Completed |
NCT03950440 -
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
|
||
Active, not recruiting |
NCT02661451 -
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
|
N/A | |
Completed |
NCT02847546 -
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
|
N/A | |
Completed |
NCT02758964 -
Evaluation of Cerebral Thrombembolism After TAVR
|
||
Completed |
NCT02792452 -
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
|
||
Not yet recruiting |
NCT02541877 -
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
|
Phase 3 | |
Not yet recruiting |
NCT02536703 -
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
|
Phase 3 | |
Completed |
NCT02249000 -
BIOVALVE - I / II Clincial Investigation
|
N/A | |
Not yet recruiting |
NCT02221921 -
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
|
N/A | |
Active, not recruiting |
NCT02080299 -
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
|
Phase 2 | |
Terminated |
NCT01939678 -
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
|