Iron DeficienciesNCT06200870
ID as a Promoter of IH-induced CAVD
An observational study of Iron Deficiencies and Calcified Aortic Valve, run by Qilu Hospital of Shandong University.
Trial summary
Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiencies, Calcified Aortic Valve
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients at the outpatient clinic or inpatient department, Qilu hospital of Shandong University, Jinan, were recruited during the period from January 2018 to March 2023.
Who may be able to join
- if performed with both color doppler echocardiography and anemia profile on admission as part of routine checkup.
Who cannot join
- if younger than the age of 18;
- if no anemia profile or doppler echocardiography was measured;
- if anemia profile or doppler echocardiography was analyzed in external laboratories;
- if had a history of rheumatic heart disease, infective endocarditis or any other congenital disorders that may implicate aortic valve structures, such as bicuspid aortic valve morphology, Marfan syndrome, and so on.
About this study
Official title: Iron Deficiency as a Promoter of Intra-leaflet Haemorrhage-induced Aortic Valve Calcification
Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Valvular interstitial cells (VICs) control the structure and function of aortic valve. Intra-leaflet haemorrhage (IH), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. In line with this, later exploration from vitro showed that iron stimulation alone could not promote VICs calcification. Iron deficiency (ID) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as CAVD; up to 50% of patients with severe aortic stenosis present ID. Data from a small clinical study in patients undergoing TAVI showed those in ID status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between ID and aortic valve remodelling and dysfunction progress itself. Here, the investigators aim to investigate for a tentative correlation between ID and human aortic valve remodeling and dysfunction.
- Conditions
- Iron Deficiencies, Calcified Aortic Valve
- Medical subject headings
- Iron Deficiencies, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aortic valvular sclerosis group | Not described | |
| non-aortic valvular sclerosis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum iron
Plasma levels of serum iron will be reported in μmol/L.
Measured: within 24 hours of admission
Total iron binding capacity
Total iron binding capacity will be reported in μmol/L.
Measured: within 24 hours of admission
Serum transferrin receptor
Plasma levels of serum transferrin receptor will be reported in g/L.
Measured: within 24 hours of admission
Unsaturated iron-binding capacity
Serum iron and total iron binding capacity will be combined to report unsaturated iron-binding capacity in μmol/L.
Measured: within 24 hours of admission
Serum transferrin
Plasma levels of serum transferrin will be reported in g/L.
Measured: within 24 hours of admission
Transferrin saturation
Serum iron and total iron binding capacity will be combined to report transferrin saturation in %.
Measured: within 24 hours of admission
Soluble transferrin index
Serum iron and serum transferrin will be combined to report soluble transferrin index.
Measured: within 24 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanbao Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200870
- Sponsor's protocol ID
- 2023IDCAVD-LCB
- Status last verified
- Dec 2023
- First submitted
- 5 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Limited by the submitted ethical protocols
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency as a Promoter of Intra-leaflet Haemorrhage-induced Aortic Valve Calcification
- ClinicalTrials.gov ID
- NCT06200870
- Acronym / sponsor ID
- 2023IDCAVD-LCB
- Conditions
- Iron Deficiencies, Calcified Aortic Valve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Valvular interstitial cells (VICs) control the structure and function of aortic valve. Intra-leaflet haemorrhage (IH), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. In line with this, later exploration from vitro showed that iron stimulation alone could not promote VICs calcification. Iron deficiency (ID) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as CAVD; up to 50% of patients with severe aortic stenosis present ID. Data from a small clinical study in patients undergoing TAVI showed those in ID status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between ID and aortic valve remodelling and dysfunction progress itself. Here, the investigators aim to investigate for a tentative correlation between ID and human aortic valve remodeling and dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aortic valvular sclerosis group | – | – |
| non-aortic valvular sclerosis group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients at the outpatient clinic or inpatient department, Qilu hospital of Shandong University, Jinan, were recruited during the period from January 2018 to March 2023.
Key inclusion criteria (1 listed)
- if performed with both color doppler echocardiography and anemia profile on admission as part of routine checkup.
Key exclusion criteria (4 listed)
- if younger than the age of 18;
- if no anemia profile or doppler echocardiography was measured;
- if anemia profile or doppler echocardiography was analyzed in external laboratories;
- if had a history of rheumatic heart disease, infective endocarditis or any other congenital disorders that may implicate aortic valve structures, such as bicuspid aortic valve morphology, Marfan syndrome, and so on.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum iron
Time frame: within 24 hours of admission
Plasma levels of serum iron will be reported in μmol/L.
Total iron binding capacity
Time frame: within 24 hours of admission
Total iron binding capacity will be reported in μmol/L.
Serum transferrin receptor
Time frame: within 24 hours of admission
Plasma levels of serum transferrin receptor will be reported in g/L.
Unsaturated iron-binding capacity
Time frame: within 24 hours of admission
Serum iron and total iron binding capacity will be combined to report unsaturated iron-binding capacity in μmol/L.
Serum transferrin
Time frame: within 24 hours of admission
Plasma levels of serum transferrin will be reported in g/L.
Transferrin saturation
Time frame: within 24 hours of admission
Serum iron and total iron binding capacity will be combined to report transferrin saturation in %.
Soluble transferrin index
Time frame: within 24 hours of admission
Serum iron and serum transferrin will be combined to report soluble transferrin index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No. Limited by the submitted ethical protocols
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiencies and Calcified Aortic Valve, run by Qilu Hospital of Shandong University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum iron (time frame: within 24 hours of admission). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.