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

NCT07105501 | Completed

• 1 other identifier: CEI: PI-19-031.
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Amyloid

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

hospital universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

A histological biobank with atrial and interventricular septum samples is available.

MeSH Terms

Conditions

Aortic Valve Stenosis; Alzheimer Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ignasi Julià, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 6, 2025
• Study Start: November 3, 2020
• Primary Completion: January 20, 2023
• Study Completion: May 20, 2023
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

ES (1)