Phenotyping Heterogeneity and Regionality of the Aorta

NCT05603520 | Recruiting

• 1 other identifier: PHaRAo
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Large Artery Stiffness; Aortic Disease; Aortic Stenosis; Aortic Aneurysm

Keywords

aortic disease; large artery stiffness; aortic stenosis; aortic aneurysm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Diastolic Dysfunction

  5 years

• Diastolic Dysfunction

  5 years

• Ejection Rate and Ejection Time

  5 years

• Ejection Rate and Ejection Time

  5 years

• Flow encoded regional MRI metrics

  5 years

Study Arms (3)

healthy volunteers

Other: Collection of Clinical Data

patients with aortic stenosis

Other: Collection of Clinical Data

patients with aortic aneurysms

Other: Collection of Clinical Data

Interventions

Collection of Clinical Data OTHER

prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms

healthy volunteers; patients with aortic aneurysms; patients with aortic stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Healthy volunteers

You may not qualify if:

• \< 18 years
• Active Medication
• Cardiovascular Disease
• MRI not possible
• Patients with Aortic Stenosis
• Patients suffering from 3rd drgree Aortic Stenosis
• \< 18 years
• MRI not possible
• Patients with Aortic Aneurysms
• Patients suffering from Aortic Aneurysms
• \< 18 years
• MRI not possible

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Christine Quast

Düsseldorf, 40225, Germany

RECRUITING

Related Publications (1)

• Quast C, Bonner F, Polzin A, Veulemans V, Chennupati R, Gyamfi Poku I, Pfeiler S, Kramser N, Nankinova M, Staub N, Zweck E, Jokiel J, Keyser F, Hoffe J, Witkowski S, Becker K, Leuders P, Zako S, Erkens R, Jung C, Flogel U, Wang T, Neidlin M, Steinseifer U, Niepmann ST, Zimmer S, Gerdes N, Cortese-Krott MM, Feelisch M, Zeus T, Kelm M. Aortic Valve Stenosis Causes Accumulation of Extracellular Hemoglobin and Systemic Endothelial Dysfunction. Circulation. 2024 Sep 17;150(12):952-965. doi: 10.1161/CIRCULATIONAHA.123.064747. Epub 2024 Jun 5.

  PMID: 38836358 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

prospectively defined blood sampling protocol

MeSH Terms

Conditions

Aortic Diseases; Aortic Valve Stenosis; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Aneurysm

Study Officials

• Malte Kelm, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine

  STUDY CHAIR

• Christine Quast, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Quast, MD

CONTACT

+492118118800; Christine.Quast@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+49211 81 05315; LisaKristina.Dannenberg@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 2, 2022
• Study Start: October 18, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)