Phenotyping Heterogeneity and Regionality of the Aorta

Aortic Stenosis Clinical Trial

— PHaRAo  

Official title:

Phenotyping Heterogeneity and Regionality of the Aorta

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603520
• Other study ID #: PHaRAo
• Status: Recruiting
• Start date: October 18, 2020
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Christine Quast, MD
• Phone: +492118118800
• Email: Christine.Quast[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

1. apparently healthy volunteers

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Disease
• Aortic Diseases
• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Other:
• Collection of Clinical Data
prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms

Locations

Country	Name	City	State
Germany	Christine Quast	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progressive accelerated Large Artery Stiffening	measured by CMR	5 years
Primary	Development of Aortic Aneurysm	measured by CMR	5 years
Primary	Progressive accelerated Large Artery Stiffening	measured by tonometry	5 years
Secondary	Diastolic Dysfunction	measured by CMR	5 years
Secondary	Diastolic Dysfunction	measured by echocardiography	5 years
Secondary	Ejection Rate and Ejection Time	measured by CMR	5 years
Secondary	Ejection Rate and Ejection Time	measured by echocardiography	5 years
Secondary	Flow encoded regional MRI metrics	measured by CMR	5 years