Human Thoracic Aorta ContractilityAorticContractNCT06374836
The Contractile Response of the Thoracic Aorta to Vasoactive Substances
An observational study of Human Thoracic Aorta Contractility, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Thoracic Aorta Contractility
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 May 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who undergo elective cardiac surgery
Who may be able to join
- Elective cardiac surgery
Who cannot join
- No informed consent for study participation Atrial fibrillation or other cause of irregular heart rhythm Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Quantify the Contractile Response of the Thoracic Aorta to Vasoactive Substances and Identify Potential Predictors of This Response.
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.
Read more
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 aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's 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 aorta's 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 use/class, mean arterial pressure, pulse pressure as an indirect measure of arterial stiffness, diabetes, chronic kidney disease, total cholesterol, and sympathetic activity) influence contractility
Read the 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.
- Conditions
- Human Thoracic Aorta Contractility
- Being tested
- Phenylephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called epihedrine, nitroprusside, nicardipine
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.
We 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish and quantify the in vivo contractility of the human thoracic aorta
The primary outcome used in this statistical analysis is the relative contractile isobaric (pressure-normalised) cross-sectional area change of the thoracic aorta (ΔCSA) to phenylephrine (ΔCSAPE).
Measured: 1 month
Secondary outcomes (2)
To quantify the magnitude of contractile response
To quantify the magnitude of contractile response ΔCSAPE with 95% confidence (α=0.05) and ≤2.5% margin of error
Measured: 2 months
To study whether and to which extent potential predictors influence contractility.
to identify predictors of the contractile response and build a realistic statistical model, in addition to using 1) pulse pressure as an indirect measure of arterial stiffness, we will assess the effects of additional potential predictors: age, sex (M/F), smoking status (yes/no), antihypertensive medication use (none/calcium channel blockers/renin-angiotensin system blockers/diuretics/nitrates, mean arterial pressure, diabetes (yes/no), chronic kidney disease (yes/no), total cholesterol, and sympathetic activity. ΔCSAPE will be expressed as a relative (with respect to pre-contraction CSA) value to account for variations in aorta size among patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start27 May 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Thoracic Aorta ContractilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Frederique de Raat, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374836
- Sponsor's protocol ID
- nWMO 2024.040
- Acronym
- AorticContract
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Raw hemodynamic data as the ultrasound acquisitions will be stored on a local server at Catharina Hospital only accessible to members of the study team. Patient characteristics, hemodynamic interventions, and laboratory results will be recorded in an electronic CRF. The CRF does not contain data that can be linked to the patient. Instead of this, a subject identification code is used in the CRF to link data to the patient if needed. The key to the code is safeguarded by the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Quantify the Contractile Response of the Thoracic Aorta to Vasoactive Substances and Identify Potential Predictors of This Response.
- ClinicalTrials.gov ID
- NCT06374836
- Acronym / sponsor ID
- AorticContract / nWMO 2024.040
- Conditions
- Human Thoracic Aorta Contractility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 27 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's 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 aorta's 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 use/class, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who undergo elective cardiac surgery
Key inclusion criteria (1 listed)
- Elective cardiac surgery
Key exclusion criteria (1 listed)
- No informed consent for study participation Atrial fibrillation or other cause of irregular heart rhythm Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenylephrineAlso: epihedrine, nitroprusside, nicardipineAt 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. We 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. | Drug | – |
Primary outcome
To establish and quantify the in vivo contractility of the human thoracic aorta
Time frame: 1 month
The primary outcome used in this statistical analysis is the relative contractile isobaric (pressure-normalised) cross-sectional area change of the thoracic aorta (ΔCSA) to phenylephrine (ΔCSAPE).
2 secondary outcomes
To quantify the magnitude of contractile response
Time frame: 2 months
To study whether and to which extent potential predictors influence contractility.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No. Raw hemodynamic data as the ultrasound acquisitions will be stored on a local server at Catharina Hospital only accessible to members of the study team. Patient characteristics, hemodynamic interventions, and laboratory results will be recorded in an electronic CRF. The CRF does not contain data that can be linked to the patient. Instead of this, a subject identification code is used in the CRF to link data to the patient if needed. The key to the code is safeguarded by the investigators.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Thoracic Aorta Contractility, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish and quantify the in vivo contractility of the human thoracic aorta (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.