The Contractile Response of the Thoracic Aorta to Vasoactive Substances

NCT ID: NCT06374836

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-27
• Study Completion Date: 2024-10-31

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 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.

Conditions

Human Thoracic Aorta Contractility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Phenylephrine

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.

Intervention Type: DRUG

Other Intervention Names

epihedrine; nitroprusside; nicardipine

Eligibility Criteria

Inclusion Criteria

• Elective cardiac surgery

Exclusion Criteria

• No informed consent for study participation Atrial fibrillation or other cause of irregular heart rhythm Emergency surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Frederique de Raat

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catharina hospital

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

nWMO 2024.040

Identifier Type: -

Identifier Source: org_study_id