Phenotyping Heterogeneity and Regionality of the Aorta

NCT ID: NCT05603520

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-18

Study Completion Date

2027-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Large Artery Stiffness Aortic Disease Aortic Stenosis Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy volunteers

Collection of Clinical Data

Intervention Type OTHER

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

patients with aortic stenosis

Collection of Clinical Data

Intervention Type OTHER

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

patients with aortic aneurysms

Collection of Clinical Data

Intervention Type OTHER

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

Interventions

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Collection of Clinical Data

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Healthy volunteers


• Patients suffering from 3rd drgree Aortic Stenosis


• Patients suffering from Aortic Aneurysms

Exclusion Criteria

* \< 18 years
* Active Medication
* Cardiovascular Disease
* MRI not possible
2. Patients with Aortic Stenosis

* \< 18 years
* MRI not possible
3. Patients with Aortic Aneurysms


* \< 18 years
* MRI not possible
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malte Kelm, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Christine Quast, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Locations

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Christine Quast

Düsseldorf, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christine Quast, MD

Role: CONTACT

+492118118800

Lisa Dannenberg, MD

Role: CONTACT

+49211 81 05315

Facility Contacts

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Christine Quast, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38836358 (View on PubMed)

Other Identifiers

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PHaRAo

Identifier Type: -

Identifier Source: org_study_id

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