Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374836
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-16
Brief Title:
The Contractile Response of the Thoracic Aorta to Vasoactive Substances
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
To Quantify the Contractile Response of the Thoracic Aorta to Vasoactive Substances and Identify Potential Predictors of This Response
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AorticContract
Brief Summary:
Hypertension affects 32-35 of the global adult population Despite many drugs being available hypertension is not controlled in 50 of the over 500 million treated people leaving patients with an elevated blood pressure for life
In the development of isolated systolic hypertension the aorta plays a pivotal role With each heartbeat the heart empties its stroke volume into the large arteries These arteries particularly the thoracic part of the aorta temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation they have a Windkessel function When this function is reduced and arterial stiffness is increased the heart needs to contract more forcefully during ejection leading to isolated systolic hypertension
Likely the aorta is not just a passive structure the aorta as an elastic bicycle tube Rather the smooth muscle cells in the aorta wall can presumably actively change the aortas dimension through vasoconstriction-dilation If this is the case such vasoconstriction-dilation will have direct consequences for the aortas Windkessel function and since this Windkessel function directly influences the blood pressure flucturation also for hypertension and its progression Therefore the aim of this study is to quantify the thoracic aortas ability to vasoconstrict and to assess whether this contractility is related to specific predictors
During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography part of standard clinical care before and after administration of vasoactive drugs phenylephrine and norepinephrine also part of standard clinical care During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram ECG to monitor sympathetic activity as estimated using heart rate variability analysis Measurements will be performed at Catharina Hospital Eindhoven the Netherlands NL where patients undergo elective cardiac surgery Using the data obtained we will 1 establish and quantify the in vivo contractility of the human thoracic aorta and 2 study whether and to which extent potential predictors age sex smoking status antihypertensive medication useclass mean arterial pressure pulse pressure as an indirect measure of arterial stiffness diabetes chronic kidney disease total cholesterol and sympathetic activity influence contractility
In the development of isolated systolic hypertension the aorta plays a pivotal role With each heartbeat the heart empties its stroke volume into the large arteries These arteries particularly the thoracic part of the aorta temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation they have a Windkessel function When this function is reduced and arterial stiffness is increased the heart needs to contract more forcefully during ejection leading to isolated systolic hypertension
Likely the aorta is not just a passive structure the aorta as an elastic bicycle tube Rather the smooth muscle cells in the aorta wall can presumably actively change the aortas dimension through vasoconstriction-dilation If this is the case such vasoconstriction-dilation will have direct consequences for the aortas Windkessel function and since this Windkessel function directly influences the blood pressure flucturation also for hypertension and its progression Therefore the aim of this study is to quantify the thoracic aortas ability to vasoconstrict and to assess whether this contractility is related to specific predictors
During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography part of standard clinical care before and after administration of vasoactive drugs phenylephrine and norepinephrine also part of standard clinical care During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram ECG to monitor sympathetic activity as estimated using heart rate variability analysis Measurements will be performed at Catharina Hospital Eindhoven the Netherlands NL where patients undergo elective cardiac surgery Using the data obtained we will 1 establish and quantify the in vivo contractility of the human thoracic aorta and 2 study whether and to which extent potential predictors age sex smoking status antihypertensive medication useclass mean arterial pressure pulse pressure as an indirect measure of arterial stiffness diabetes chronic kidney disease total cholesterol and sympathetic activity influence contractility
Detailed Description:
At the OR the patient will be sedated and have a transoesophageal echo TEE catether inserted which is part of standard clinical care When a patient becomes hypotensive and the attending anesthesiologist decides to infuse any of the following drugs phenylephrine ephedrine norepinephrine nitroprusside or nicardipine before infusion the anesthesiolgist will acquire with TEE 10 beats of the thoracic ascending and descending aorta respectively This is defined as one measurement Five minutes after infusion the same measurement is repeated A maximum of 10 measurements 5 before and 5 after infusion of a drug per patient will be performed
The investigators want to explicitly mention that for study purposes the surgery or anesthesia will never be prolonged or modified nor will any drugs be give for study purposes
The investigators want to explicitly mention that for study purposes the surgery or anesthesia will never be prolonged or modified nor will any drugs be give for study purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None