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NCT Number: NCT05603520

Phenotyping Heterogeneity and Regionality of the Aorta

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

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Key information

Conditions

Large Artery Stiffness Aneurysm Aortic Aneurysm Aortic Disease Aortic Diseases Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Christine Quast

Düsseldorf, 40225, Germany

Location status: Recruiting

Location contact

Christine Quast, MD

CONTACT

[email protected]

Christine Quast, MD

PRINCIPAL_INVESTIGATOR

Josephin Cebulla

SUB_INVESTIGATOR

Magdalena Nankinova

SUB_INVESTIGATOR

Malte Kelm, Prof, MD

PRINCIPAL_INVESTIGATOR

Pia Leuders, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • apparently healthy volunteers

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • < 18 years
  • Active Medication
  • Cardiovascular Disease
  • MRI not possible
  • Patients with Aortic Stenosis

Inclusion criteria

  • Patients suffering from 3rd drgree Aortic Stenosis

Exclusion criteria

  • < 18 years
  • MRI not possible
  • Patients with Aortic Aneurysms

Inclusion criteria

  • Patients suffering from Aortic Aneurysms

Exclusion criteria

  • < 18 years
  • MRI not possible

Treatment and study plan

collection of clinical data

Other

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

Primary outcomes

  1. Progressive accelerated Large Artery Stiffening

    Time frame: 5 years

    measured by CMR

  2. Development of Aortic Aneurysm

    Time frame: 5 years

    measured by CMR

  3. Progressive accelerated Large Artery Stiffening

    Time frame: 5 years

    measured by tonometry

Secondary outcomes

  1. Diastolic Dysfunction

    Time frame: 5 years

    measured by CMR

  2. Diastolic Dysfunction

    Time frame: 5 years

    measured by echocardiography

  3. Ejection Rate and Ejection Time

    Time frame: 5 years

    measured by CMR

  4. Ejection Rate and Ejection Time

    Time frame: 5 years

    measured by echocardiography

  5. Flow encoded regional MRI metrics

    Time frame: 5 years

    measured by CMR

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Quast, MD

CONTACT

[email protected]

+492118118800

Lisa Dannenberg, MD

CONTACT

[email protected]

+49211 81 05315

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Acronym: PHaRAo

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Nov 2, 2022
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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