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Recruiting NCT05603520

Phenotyping Heterogeneity and Regionality of the Aorta

Observational Large Artery Stiffness Aortic Disease Aortic Stenosis Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collection of Clinical Data.
Who it may be relevant to
Registry conditions: Large Artery Stiffness, Aortic Disease, Aortic Stenosis, Aortic Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

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

Primary outcome measures

  • Progressive accelerated Large Artery Stiffening [Time frame: 5 years]
  • Development of Aortic Aneurysm [Time frame: 5 years]
  • Progressive accelerated Large Artery Stiffening [Time frame: 5 years]
Secondary outcome measures (5)
  • Diastolic Dysfunction [Time frame: 5 years]
  • Diastolic Dysfunction [Time frame: 5 years]
  • Ejection Rate and Ejection Time [Time frame: 5 years]
  • Ejection Rate and Ejection Time [Time frame: 5 years]
  • Flow encoded regional MRI metrics [Time frame: 5 years]

Eligibility criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Christine Quast — Düsseldorf

Publications

  • 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 Hemog PMID 38836358

Identifiers

NCT: NCT05603520 · PHaRAo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗