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Completed

NCT Number: NCT07105501

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

hospital universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. NT-proBNP levels

    Time frame: From enrollment to the one-year follow-up

    NT-proBNP preoperative and follow-up levels in each group

  2. Metrnl levels

    Time frame: from enrollment to the one-year follow-up

    Metrnl preoperative and follow up levels

  3. New-onset postoperative atrial fibrillation

    Time frame: From enrollment to the one-year follow-up

    New presence of postoperative atrial fibrillation

  4. Hospital readmission

    Time frame: From enrollment to the one - year follow-up

    Hospital readmission in the first year follow-up

  5. 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.

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

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

Acronym: AORTICMARKER

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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