ClinicalTrials.gov record NCT06836011

A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationAustria, Germany, Italy, Netherlands
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective international registry will characterize mitral and tricuspid valve regurgitation in people with transthyretin amyloid cardiomyopathy (ATTR‑CM). It collects standardized echocardiographic measurements and follows participants for clinical outcomes for up to 60 months. The study aims to develop new grading standards for regurgitation severity adapted to the ATTR‑CM heart profile.

What it is studying. The study is testing how common mitral and tricuspid regurgitation are in ATTR‑CM, how to measure and grade their severity using standardized echocardiography tailored to ATTR‑CM's restrictive heart features, and whether these measures are linked with outcomes such as death and heart‑failure hospitalizations.

What the researchers hope to learn. To define the prevalence and severity measures of mitral and tricuspid regurgitation in ATTR‑CM; to develop and implement quantitative grading standards suited to ATTR‑CM; and to assess associations between regurgitation measures and clinical outcomes up to 60 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of ATTR-CM. This approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in ATTR-CM.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Diagnosis of ATTR-CM according to current diagnostic criteria
  • Comprehensive baseline echocardiographic assessment, including (semi-)quantitative mitral and tricuspid regurgitation (MR/TR) parameters, performed within ±6 months of diagnosis
  • Age ≥ 18 years
  • Willingness to participate in the study and provide informed consent

Exclusion criteria

  • Severe aortic valve disease requiring intervention
  • Inability to provide informed consent or participate in study follow-up

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Provide informed consent and allow the study to collect and analyze their clinical records and echocardiography data. A comprehensive baseline echocardiogram (including semi-quantitative mitral and tricuspid regurgitation measures taken within ±6 months of diagnosis) will be collected or reviewed according to the study protocol. Researchers will track clinical outcomes, including all-cause and cardiovascular death and heart-failure hospitalizations, for up to 60 months. The registry record does not list additional invasive procedures beyond echocardiographic assessments.

How the study is structured. A prospective observational registry: participating centers collect standardized baseline echocardiograms (including semi‑quantitative and quantitative MR/TR measures) and follow patients over time (up to 60 months) to record outcomes like all‑cause and cardiovascular mortality and heart‑failure hospitalizations. No experimental treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under ATTR Amyloidosis With Cardiomyopathy; ATTR-CM; ATTR Amyloidosis Wild Type; Mitral Regurgitation; Tricuspid Regurgitation. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Austria, Germany, Italy, Netherlands. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 1, 2025
Primary completion
Dec 31, 2025 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
600 participants (estimated)
Last updated on registry
Feb 19, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Medical University of Vienna
Principal investigator
Christian Nitsche, Priv.-Doz. Dr. med. univ., PhD
Medical University of Vienna

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (8)

  • Medical University of GrazRecruiting

    Graz, Styria, 8010 · Austria

  • Department of Internal Medicine II, Medical University of ViennaRecruiting

    Vienna, 1090 · Austria

  • Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-UniversityRecruiting

    Munich, Bavaria, 81377 · Germany

  • Department of Cardiology, University Hospital Frankfurt, Goethe UniversityRecruiting

    Frankfurt am Main, Hesse, 60596 · Germany

  • Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of BresciaRecruiting

    Brescia, 25100 · Italy

  • Cardiologic Centre, Azienda Ospedaliero Universitaria di FerraraRecruiting

    Ferrara, 44121 · Italy

  • Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of TriesteRecruiting

    Trieste, 34100 · Italy

  • University Medical Center UtrechtRecruiting

    Utrecht, 3450 · Netherlands

    • Marish I.F.J. Oerlemans, Ass. Prof. Dr. · 0000 · moerlem4@umcutrecht.nl
    • Marish I.F.J. Oerlemans, Ass. Prof. Dr.
    • Steven A Muller, Dr.

Terms used on this page · explanations by MedicalUpdates.ai

registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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