Skip to content

Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement

Hidden Auricular Amyloid Deposits and Aortic Stenosis: Clinical and Prognostic Implications in Aortic Valve Replacement Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07105501
Acronym
AORTICMARKER
Enrollment
110
Registered
2025-08-06
Start date
2020-11-03
Completion date
2023-05-20
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloid, Aortic Stenosis

Keywords

Aortic valve replacement surgery, Amyloid, Atrial deposits, Biomarkers, spatial transcriptomics

Brief 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. 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.

Interventions

None listed

Sponsors

Germans Trias i Pujol Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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).

Design outcomes

Primary

MeasureTime frameDescription
NT-proBNP levelsFrom enrollment to the one-year follow-upNT-proBNP preoperative and follow-up levels in each group
Metrnl levelsfrom enrollment to the one-year follow-upMetrnl preoperative and follow up levels
New-onset postoperative atrial fibrillationFrom enrollment to the one-year follow-upNew presence of postoperative atrial fibrillation
Hospital readmissionFrom enrollment to the one - year follow-upHospital readmission in the first year follow-up
Postoperative quality of lifeFrom enrollment to the one-year follow-upUse 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026