ClinicalTrials.gov record NCT06799273

MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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 to 100 years old

SexAll

LocationItaly

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 observational study follows people with cardiac amyloidosis to study how exercise capacity relates to outcomes. Participants in the amyloidosis group are evaluated every six months for two years. The study will compare results with a retrospective group of heart-failure patients from the MECKI score database.

What it is studying. Whether measures of exercise capacity and other clinical data are linked to two-year prognosis in cardiac amyloidosis, and whether a MECKI-like risk score can be created for these patients. It also compares prognosis and exercise limitations between cardiac amyloidosis and general heart failure.

What the researchers hope to learn. Identify which exercise-related and clinical measurements best predict two-year outcomes in cardiac amyloidosis; develop a disease-specific prognostic score; and describe how exercise limitations and prognosis differ from general heart failure.

What this study is about

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

This study aims to advance the understanding of cardiac amyloidosis, its effects on exercise capacity, and its prognostic implications. By conducting a systematic investigation with particular emphasis on longitudinal evaluation, we aim to provide valuable insights to guide clinical practice and improve the management of patients with cardiac amyloidosis. Our study intends to follow patients for a period of two years, evaluating them every six months. This longitudinal approach allows us to monitor changes in exercise capacity and other relevant clinical parameters over time. Furthermore, it enables the development of a prognostic tool similar to the MECKI score, capable of assessing the risk of adverse events in patients with cardiac amyloidosis based on their exercise performance. By comparing our results with data from heart failure patients already included in the MECKI score database, we also aim to highlight any differences in prognosis between patients with cardiac amyloidosis and those with general heart failure. Finally, we aim to characterize cardiac amyloidosis by differentiating it from general heart failure. By comparing our results with data from heart failure patients already included in the MECKI score database, we can clarify the distinct exercise limitations in cardiac amyloidosis and shed light on how they differ from more conventional heart failure.

Eligibility

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

Inclusion criteria

Age > 18 years
Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy
Ability to perform a cardiopulmonary exercise test

Exclusion criteria

severe obstructive pulmonary disease
exercise-induced angina
significant ECG changes
presence of clinical comorbidities that interfere with exercise performance

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.

Participants in the prospective arm will be followed for two years with study visits every six months to evaluate exercise capacity and other clinical measures. The study requires that you already have a diagnosis of cardiac amyloidosis made by MRI or scintigraphy and that you are able to perform a cardiopulmonary exercise test; the record does not say the study will perform MRI or scintigraphy itself. The record says the study will use repeated exercise assessments to develop a specific risk score and to compare results with existing MECKI heart-failure data, but it does not list other specific tests, samples, or procedures performed at each visit.

How the study is structured. A prospective cohort study of patients diagnosed with cardiac amyloidosis, followed every six months for two years. A retrospective cohort of heart-failure patients from the existing MECKI score database will be used for comparison. No treatments are assigned by the study.

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 Cardiac Amyloidosis. 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 Italy. 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 ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 7, 2024
Primary completion: May 2026 (estimated)
Study completion: May 2027 (estimated)
Target enrollment: 1400 participants (estimated)
Last updated on registry: Jan 29, 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: Centro Cardiologico Monzino

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.

piergiuseppe Agostoni, MD, PhD 📞 0258002772 ✉ piergiuseppe.agostoni@cardiologicomonzino.it

Participating sites (1)

Centro Cardiologico Monzino, IrccsRecruiting
Milan, Italy, 20138 · Italy
- Piergiuseppe Agostoni · 0258002010 · piergiuseppe.agostoni@ccfm.it

Terms used on this page · explanations by MedicalUpdates.ai

adverse events: Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
ECG: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
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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