Phenotyping Heterogeneity and Regionality of the Aorta (PHaRAo)

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Aortic Aneurysm; Aortic Disease; Large Artery Stiffness
• Intervention / Treatment: Other: Collection of Clinical Data

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Lisa Dannenberg, MD; Phone Number: +49211 81 05315; Email: LisaKristina.Dannenberg@med.uni-duesseldorf.de
• Study Contact Backup: Name: Christine Quast, MD; Phone Number: +492118118800; Email: Christine.Quast@med.uni-duesseldorf.de

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Christine Quast
    • Principal Investigator: Malte Kelm, Prof, MD
    • Contact: Christine Quast, MD; Email: Christine.Quast@med.uni-duesseldorf.de
    • Principal Investigator: Christine Quast, MD
    • Sub-Investigator: Josephin Cebulla
    • Sub-Investigator: Pia Leuders, MD
    • Sub-Investigator: Magdalena Nankinova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers, patients with aortic stenosis, patients with aortic aneurysm

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	Other: Collection of Clinical Data; prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms
patients with aortic stenosis	Other: Collection of Clinical Data; prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms
patients with aortic aneurysms	Other: Collection of Clinical Data; prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive accelerated Large Artery Stiffening	measured by CMR	5 years
Development of Aortic Aneurysm	measured by CMR	5 years
Progressive accelerated Large Artery Stiffening	measured by tonometry	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Dysfunction	measured by CMR	5 years
Diastolic Dysfunction	measured by echocardiography	5 years
Ejection Rate and Ejection Time	measured by CMR	5 years
Ejection Rate and Ejection Time	measured by echocardiography	5 years
Flow encoded regional MRI metrics	measured by CMR	5 years

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine; Principal Investigator: Christine Quast, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: aortic stenosis; aortic aneurysm; aortic disease; large artery stiffness
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aneurysm; Aortic Aneurysm; Aortic Diseases
• Other Study ID Numbers: PHaRAo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No