Aortic StenosisAORTICMARKERNCT07105501
Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement
An observational study of Aortic Stenosis and Amyloid, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
Background (Context): Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart. These protein clumps, known as amyloid, are more often found in people with a certain condition called amyloidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Amyloid
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 3 Nov 2020to 20 May 2023
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort includes consecutive patients who underwent isolated aortic valve replacement at Germans Trias i Pujol Hospital, and who met the inclusion criteria.
Who may be able to join
- Over 18 years of age.
- Signed specific informed consent (see attached).
- Severe aortic stenosis with surgical indication.
- Elective isolated aortic valve replacement surgery via full or partial median sternotomy.
Who cannot join
- Urgent or emergency surgery (patients in cardiogenic shock, under intra-aortic balloon pump therapy or any other mechanical support, or receiving vasoactive drugs).
- Combined surgery with any additional procedure.
- Ischemic heart disease with significant lesions confirmed by preoperative invasive catheterization, with or without concomitant revascularization during aortic valve replacement surgery.
- Concomitant endocarditis.
- Inability to collect surgical tissue samples. Initially, all patients with at least one histological sample were included; later, only those with both atrial and septal samples were analyzed.
- Extracardiac disease with a life expectancy of less than 365 days.
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- Patient with a previous and/or current diagnosis of any form of amyloidosis.
- Surgical access other than full or partial median sternotomy.
- Patients with severe aortic stenosis but with a TAVI indication as decided by a multidisciplinary heart team (including interventional cardiology, clinical cardiology, and cardiac surgery).
Trial locations and contacts
1 site in 1 country.
Spain1 site
hospital universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
About this study
Official title: Hidden Auricular Amyloid Deposits and Aortic Stenosis: Clinical and Prognostic Implications in Aortic Valve Replacement Surgery
Background (Context):
Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart. These protein clumps, known as amyloid, are more often found in people with a certain condition called amyloidosis. However, in many cases, these deposits are found only in the upper chambers of the heart (called atria) and without any previous diagnosis of the disease. The meaning and health impact of these hidden amyloid deposits are still unclear.
Read more
Objectives (What the investigators wanted to find out):
This study aimed to understand how common these protein deposits are in people with aortic valve disease, what this deposits are made of, and how they affect recovery and health after heart surgery. To do this, various types of analysis were combined, including tissue samples, blood tests, and advanced genetic studies.
Methods (What the investigators did):
Seventy patients undergoing surgery to replace the aortic valve were studied. During the operation, small samples were collected from the top part of the heart and analyzed in the lab using special dyes and microscopes. Substances in blood were also measured, and health status was monitored over the following year. For some samples, advanced genetic tools were used to investigate processes at the level of individual cells.
Read the detailed description
The study aims to find out whether deposits of amyloid (an abnormal protein that builds up in tissues) in the upper chambers of the heart are linked to worse recovery after aortic valve replacement surgery. For example, it looks at whether these deposits are related to hospital readmissions, irregular heart rhythms, or problems with kidney function after surgery.
- Conditions
- Aortic Stenosis, Amyloid
- Keywords
- Aortic valve replacement surgery, Amyloid, Atrial deposits, Biomarkers, spatial transcriptomics
- Medical subject headings
- Aortic Valve Stenosis, Alzheimer Disease
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 |
|---|---|---|
| CONGO + | Patients with amyloid deposits in atrial histological samples. As this is an observational study, no intervention was performed on the subcohort, which was defined as CONGO+ based on the presence of amyloid deposits observed in atrial samples collected during surgery. | |
| CONGO - | Patients without amyloid deposits in atrial histological samples. As this is an observational study, no intervention was performed on the subcohort, which was defined as CONGO- based on the no presence of amyloid deposits observed in atrial samples collected during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP levels
NT-proBNP preoperative and follow-up levels in each group
Measured: From enrollment to the one-year follow-up
Metrnl levels
Metrnl preoperative and follow up levels
Measured: from enrollment to the one-year follow-up
New-onset postoperative atrial fibrillation
New presence of postoperative atrial fibrillation
Measured: From enrollment to the one-year follow-up
Hospital readmission
Hospital readmission in the first year follow-up
Measured: From enrollment to the one - year follow-up
Postoperative quality of life
Use of the EuroQuol subjectives health test preoperatively and at one-year follow-up. The test completed title is EuroQuol 5D-5L (or EQ-5D-5L), and it consists of a final score ranging from 0 to 100 points, with 0 representing the worst possible health and 100 the best.
Measured: From enrollment to the one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start3 Nov 2020
- Primary completion20 Jan 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- 110 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignasi Julià, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105501
- Sponsor's protocol ID
- CEI: PI-19-031.
- Acronym
- AORTICMARKER
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hidden Auricular Amyloid Deposits and Aortic Stenosis: Clinical and Prognostic Implications in Aortic Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT07105501
- Acronym / sponsor ID
- AORTICMARKER / CEI: PI-19-031.
- Conditions
- Aortic Stenosis, Amyloid
- Keywords
- Aortic valve replacement surgery, Amyloid, Atrial deposits, Biomarkers, spatial transcriptomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 6 Aug 2025 (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.
Background (Context):
Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart. These protein clumps, known as amyloid, are more often found in people with a certain condition called amyloidosis. However, in many cases, these deposits are found only in the upper chambers of the heart (called atria) and without any previous diagnosis of the disease. The meaning and health impact of these hidden amyloid deposits are still unclear.
Objectives (What the investigators wanted to find out):
This study aimed to understand how common these protein deposits are in people with aortic valve disease, what this deposits are made of, and how they affect recovery and health after heart surgery. To do this, various types of analysis were combined, including tissue samples, blood tests, and advanced genetic studies.
Methods (What the investigators did):
Seventy patients undergoing surgery to replace the aortic valve were studied. During the operation, small samples were collected from the top part of the heart and analyzed in the lab using special dyes and microscopes. Substances in blood were also measured, and health status was monitored over the following year. For some samples, advanced genetic tools were used to investigate processes at the level of individual cells.
Detailed description
The study aims to find out whether deposits of amyloid (an abnormal protein that builds up in tissues) in the upper chambers of the heart are linked to worse recovery after aortic valve replacement surgery. For example, it looks at whether these deposits are related to hospital readmissions, irregular heart rhythms, or problems with kidney function after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONGO + | – | –Patients with amyloid deposits in atrial histological samples. As this is an observational study, no intervention was performed on the subcohort, which was defined as CONGO+ based on the presence of amyloid deposits observed in atrial samples collected during surgery. |
| CONGO - | – | –Patients without amyloid deposits in atrial histological samples. As this is an observational study, no intervention was performed on the subcohort, which was defined as CONGO- based on the no presence of amyloid deposits observed in atrial samples collected during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort includes consecutive patients who underwent isolated aortic valve replacement at Germans Trias i Pujol Hospital, and who met the inclusion criteria.
Key inclusion criteria (4 listed)
- Over 18 years of age.
- Signed specific informed consent (see attached).
- Severe aortic stenosis with surgical indication.
- Elective isolated aortic valve replacement surgery via full or partial median sternotomy.
Key exclusion criteria (9 listed)
- Urgent or emergency surgery (patients in cardiogenic shock, under intra-aortic balloon pump therapy or any other mechanical support, or receiving vasoactive drugs).
- Combined surgery with any additional procedure.
- Ischemic heart disease with significant lesions confirmed by preoperative invasive catheterization, with or without concomitant revascularization during aortic valve replacement surgery.
- Concomitant endocarditis.
- Inability to collect surgical tissue samples. Initially, all patients with at least one histological sample were included; later, only those with both atrial and septal samples were analyzed.
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
NT-proBNP levels
Time frame: From enrollment to the one-year follow-up
NT-proBNP preoperative and follow-up levels in each group
Metrnl levels
Time frame: from enrollment to the one-year follow-up
Metrnl preoperative and follow up levels
New-onset postoperative atrial fibrillation
Time frame: From enrollment to the one-year follow-up
New presence of postoperative atrial fibrillation
Hospital readmission
Time frame: From enrollment to the one - year follow-up
Hospital readmission in the first year follow-up
Postoperative quality of life
Time frame: From enrollment to the one-year follow-up
Use of the EuroQuol subjectives health test preoperatively and at one-year follow-up. The test completed title is EuroQuol 5D-5L (or EQ-5D-5L), and it consists of a final score ranging from 0 to 100 points, with 0 representing the worst possible health and 100 the best.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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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.
Ignasi Julià, MD principal investigator
Germans Trias i Pujol Hospital
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 Aortic Stenosis and Amyloid, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 6 Aug 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NT-proBNP levels (time frame: From enrollment to the one-year follow-up). The study lists 5 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 6 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.