Large Artery StiffnessPHaRAoNCT05603520
Phenotyping Heterogeneity and Regionality of the Aorta
An observational study of Large Artery Stiffness and Aortic Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Large Artery Stiffness, Aortic Disease, Aortic Stenosis
- What is being tested?
- Collection of Clinical Data
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 18 Oct 2020to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers, patients with aortic stenosis, patients with aortic aneurysm
Who may be able to join
- Healthy volunteers
- Patients suffering from 3rd drgree Aortic Stenosis
- Patients suffering from Aortic Aneurysms
Who cannot join
- < 18 years
- Active Medication
- Cardiovascular Disease
- MRI not possible
- Patients with Aortic Stenosis
- < 18 years
Show all 10Show fewer
- MRI not possible
- Patients with Aortic Aneurysms
- < 18 years
- MRI not possible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Christine Quast
Düsseldorf, 40225
Christine Quast, MD, Christine.Quast@med.uni-duesseldorf.de
Christine Quast, MD
About this study
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
- Being tested
- Collection of Clinical Data
- Keywords
- aortic disease, large artery stiffness, aortic stenosis, aortic aneurysm
- Medical subject headings
- Aortic Diseases, Aortic Valve Stenosis, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Clinical DataOther
prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described Receives: Other: Collection of Clinical Data | |
| patients with aortic stenosis | Not described Receives: Other: Collection of Clinical Data | |
| patients with aortic aneurysms | Not described Receives: Other: Collection of Clinical Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive accelerated Large Artery Stiffening
measured by CMR
Measured: 5 years
Development of Aortic Aneurysm
measured by CMR
Measured: 5 years
Progressive accelerated Large Artery Stiffening
measured by tonometry
Measured: 5 years
Secondary outcomes (5)
Diastolic Dysfunction
measured by CMR
Measured: 5 years
Diastolic Dysfunction
measured by echocardiography
Measured: 5 years
Ejection Rate and Ejection Time
measured by CMR
Measured: 5 years
Ejection Rate and Ejection Time
measured by echocardiography
Measured: 5 years
Flow encoded regional MRI metrics
measured by CMR
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start18 Oct 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Artery StiffnessStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular MedicineChristine Quast, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603520
- Sponsor's protocol ID
- PHaRAo
- Acronym
- PHaRAo
- Status last verified
- Jan 2024
- First submitted
- 24 Oct 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Hemoglobin and Systemic Endothelial Dysfunction. Circulation. 2024 Sep 17;150(12):952-965. doi: 10.1161/CIRCULATIONAHA.123.064747. Epub 2024 Jun 5.
PubMed 38836358
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Heterogeneity and Regionality of the Aorta
- ClinicalTrials.gov ID
- NCT05603520
- Acronym / sponsor ID
- PHaRAo / PHaRAo
- Keywords
- aortic disease, large artery stiffness, aortic stenosis, aortic aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers, patients with aortic stenosis, patients with aortic aneurysm
Key inclusion criteria (3 listed)
- Patients suffering from Aortic Aneurysms
Key exclusion criteria (10 listed)
- Patients with Aortic Stenosis
- Patients with Aortic Aneurysms
- < 18 years
- MRI not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of Clinical Dataprospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms | Other | healthy volunteers, patients with aortic aneurysms, patients with aortic stenosis |
Primary outcome
Progressive accelerated Large Artery Stiffening
Time frame: 5 years
measured by CMR
Development of Aortic Aneurysm
Time frame: 5 years
measured by CMR
Progressive accelerated Large Artery Stiffening
Time frame: 5 years
measured by tonometry
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 38836358Quast 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large Artery Stiffness and Aortic Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Quast, MD (+492118118800, Christine.Quast@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive accelerated Large Artery Stiffening (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.