Phenotyping Heterogeneity and Regionality of the Aorta

Recruiting

• Conditions: Aortic Aneurysm; Large Artery Stiffness; Aortic Stenosis; Aortic Disease
• Interventions: Other: Collection of Clinical Data

• Registration Number: NCT05603520
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

The aorta distributes cardiac stroke volume into the whole body through its finetuned conductance function, that is propagation and modulation of flow pattern. Physicomechanic properties of the aortic wall assure continuous and homogenous blood flow distribution to organs. The physicomechanic properties of the aortic wall are heterotopic: The collagen/elastin ratio doubles in the abdominal aorta as compared to the thoracic aorta. Malfunction of aortic conduction due to large artery stiffening (LAS) leads to premature wave reflection and excess pulsatility which translate into organ damage in low-resistance beds. The regional heterogeneity of aortic physicomechanic properties and their histomorphological substrate leading to altered regional hemodynamics are not well investigated.

Within the PHaRAo population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from PHaRAo patients. This cohort study is an open-end observational study to identify master switches in aortic disease

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-18
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• < 18 years
  • Active Medication
  • Cardiovascular Disease
  • MRI not possible

2. Patients with Aortic Stenosis

   Inclusion Criteria:

   • Patients suffering from 3rd drgree Aortic Stenosis

   Exclusion Criteria:

   • < 18 years
   • MRI not possible

3. Patients with Aortic Aneurysms

Inclusion Criteria:

• Patients suffering from Aortic Aneurysms

Exclusion Criteria:

• < 18 years
• MRI not possible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy volunteers	Collection of Clinical Data	-
patients with aortic stenosis	Collection of Clinical Data	-
patients with aortic aneurysms	Collection of Clinical Data	-

Primary Outcome Measures

Name	Time	Method
Progressive accelerated Large Artery Stiffening	5 years	measured by tonometry
Development of Aortic Aneurysm	5 years	measured by CMR

Secondary Outcome Measures

Name	Time	Method
Diastolic Dysfunction	5 years	measured by echocardiography
Ejection Rate and Ejection Time	5 years	measured by echocardiography
Flow encoded regional MRI metrics	5 years	measured by CMR

Trial Locations

Locations (1)

Christine Quast; 🇩🇪 Düsseldorf, Germany