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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP levels | NT-proBNP preoperative and follow-up levels in each group | From enrollment to the one-year follow-up |
| Metrnl levels | Metrnl preoperative and follow up levels | from enrollment to the one-year follow-up |
| New-onset postoperative atrial fibrillation | New presence of postoperative atrial fibrillation | From enrollment to the one-year follow-up |
| Hospital readmission | Hospital readmission in the first year follow-up | 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. | From enrollment to the one-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The study cohort includes consecutive patients who underwent isolated aortic valve replacement at Germans Trias i Pujol Hospital, and who met the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Ignasi JuliĆ , MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hospital universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2023 | Aug 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2020 | Aug 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A histological biobank with atrial and interventricular septum samples is available.
| D014694 |
| Ventricular Outflow Obstruction |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |