ClinicalTrials.gg
RecruitingNCT05603520PHaRAoUpdated Jan 10, 2024

Phenotyping Heterogeneity and Regionality of the Aorta

An observational study in Large Artery Stiffness, Aortic Disease and Aortic Stenosis, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-10.

Primary conditionAortic AneurysmRegistry: Aortic DiseasesReclassifiedWhy we changed it
Registry
Aortic Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aortic Aneurysm
Why
  1. The study's listed conditions name Aortic Aneurysm, a narrower term within Aortic Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Heinrich-Heine University, Duesseldorf · Observational

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Large Artery Stiffness
  • Aortic Disease
  • Aortic Stenosis
  • Aortic Aneurysm

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Keywords

  • aortic disease
  • large artery stiffness
  • aortic stenosis
  • aortic aneurysm
03

In context

Aortic Aneurysm Reclassified

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 300 is above the median of 150 across 117 observational studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.

Compared within Aortic Aneurysm, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

  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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherCollection of Clinical Data

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

06

What researchers measure

Primary outcomes

  1. Progressive accelerated Large Artery Stiffening

    measured by CMR

    Time frame: 5 years

  2. Development of Aortic Aneurysm

    measured by CMR

    Time frame: 5 years

  3. Progressive accelerated Large Artery Stiffening

    measured by tonometry

    Time frame: 5 years

Secondary outcomes

  1. Diastolic Dysfunction

    measured by CMR

    Time frame: 5 years

  2. Diastolic Dysfunction

    measured by echocardiography

    Time frame: 5 years

  3. Ejection Rate and Ejection Time

    measured by CMR

    Time frame: 5 years

  4. Ejection Rate and Ejection Time

    measured by echocardiography

    Time frame: 5 years

  5. Flow encoded regional MRI metrics

    measured by CMR

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Christine Quast
    Düsseldorf, 40225, Germany
    Recruiting
    • Christine Quast, MD · ContactChristine.Quast@med.uni-duesseldorf.de
    • Christine Quast, MD · Principal investigator
    • Malte Kelm, Prof, MD · Principal investigator
    • Josephin Cebulla · Sub investigator
    • Pia Leuders, MD · Sub investigator
    • Magdalena Nankinova · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05603520
Responsible party
Sponsor
First posted
Nov 2, 2022
Start date
Oct 18, 2020
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jan 10, 2024

Study contacts

Christine Quast, MD
Contact
Christine.Quast@med.uni-duesseldorf.de
+492118118800
Lisa Dannenberg, MD
Contact
LisaKristina.Dannenberg@med.uni-duesseldorf.de
+49211 81 05315
Malte Kelm, MD
study chair · Division of Cardiology, Pulmonary Disease and Vascular Medicine
Christine Quast, MD
principal investigator · Division of Cardiology, Pulmonary Disease and Vascular Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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