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

NCT ID: NCT07105501

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2023-05-20

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.

Conditions

Aortic Stenosis; Amyloid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ignasi Julià, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

hospital universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CEI: PI-19-031.

Identifier Type: -

Identifier Source: org_study_id