ClinicalTrials.gov record NCT06291805

Phenotyping and Characterization of wtATTR-CM (TRACE 1)

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

Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional 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.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationDenmark
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.

A cross-sectional observational study of 100 people with wild-type transthyretin cardiac amyloidosis (ATTRwt‑CM) and 20 healthy, age- and sex-matched controls. It collects clinical exams, imaging, blood and urine samples, and quality-of-life questionnaires to study links between disease severity, biomarkers, and patient-reported quality of life. A small subgroup may have an endomyocardial biopsy.

What it is studying. Whether worse ATTRwt‑CM by clinical, biochemical, and imaging measures is linked to poorer quality of life, and whether misfolded (misTTR) and fragmented transthyretin (fragTTR) can be measured in plasma, urine, and endomyocardial biopsies and relate to disease severity. The study also compares the ATTR‑QoL questionnaire with other QoL tools.

What the researchers hope to learn. To describe how disease severity relates to patient quality of life; to detect and measure total, misfolded, and fragmented transthyretin in plasma, urine, and biopsies; to compare and validate the ATTR‑QoL questionnaire against other QoL measures; and to identify imaging and biomarker tools that could help evaluate and monitor ATTRwt‑CM progression and response to treatment.

What this study is about

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

Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity.

Eligibility

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

Inclusion criteria

  • Group 1: wtATTR-CM patients
  • Patients > 18 years diagnosed with ATTRwt-CM by:
  • endomyocardial biopsy
  • DPD scintigraphy with Perugini grade 2-3 where variant amyloidosis is ruled out due to genetic testing.
  • Informed oral and written consent

Exclusion criteria

  • AL amyloidosis (light-chain amyloidosis).
  • Myelomatosis
  • Waldenström macroglobulinemia
  • Group 2: Control group
  • Patients > 18 years
  • Informed oral and written consent
  • Known cardiovascular disease including ischemic heart disease, heart failure, atrial fibrillation, presence of a pacemaker, or malignant hypertension. Well-controlled hypertension is acceptable.
  • Suspicion of cardiac amyloidosis assessed through clinical history, physical examination, ECG, and echocardiography focusing on "red flags":
  • Echocardiography with:
  • Myocardial hypertrophy (septum >11 mm)
  • Apical sparing in LV-GLS
  • Infiltrative changes in the right ventricle free wall, thickened atrioventricular valves, or thickened atrial septum
  • Symptoms of polyneuropathy
  • Low voltage on ECG or discrepancy between left ventricular thickness and ECG amplitude indicative of low voltage
  • Atrioventricular block (AV block)
  • Bilateral carpal tunnel syndrome
  • Surgery for spinal stenosis
  • Elevated troponin I or NT-pro-BNP

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Hypothesis:

  • We hypothesize that more severe wild-type amyloidosis cardiomyopathy (ATTRwt-CM) according to clinical, biochemical, and diagnostic imaging parameters are correlated with worse quality of life (QoL) for patients.
  • We expect misfolded (misTTR) and/or fragmented transthyretin (fragTTR) to be measurable in plasma and/or urine and fragTTR to be detectable in endomyocardial biopsies from patients with ATTRwt-CM. We expect the values of misTTR and fragTTR to be correlated with the severity of ATTRwt-CM according to clinical, biochemical, and diagnostic imaging parameters. We expect the level of fragTTR from endomyocardial biopsies to be correlated with plasma levels of fragTTR.

Method: ATTRwt-CM patients: Prospective inclusion of 100 consecutive ATTRwt-CM patients reflecting all NAC stages (40 patients from NAC disease stage 1, 40 patients from NAC disease stage II and 20 patients from NAC disease stage III). Patients will be recruited from the out-patient amyloidosis clinic at Aarhus University hospital. Patients will be thoroughly clinically assessed. Control patients: A control cohort of 20 age- and gender-matched heart-healthy patients will be included for comparison of total/mis-/fragTTR values. The investigating into QoL, bio markers and the analyses on cardiac MR imaging markers will hopefully provide us with tools to evaluate and monitor disease progression and response to treatment.

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.

Patients will have a clinical visit with history and physical exam, ECG, advanced echocardiography, blood and urine samples, cardiac magnetic resonance imaging (CMR), and complete quality‑of‑life questionnaires (KCCQ, EQ‑5D‑5L and ATTR‑QoL). A subgroup of patients (about 10) may undergo an endomyocardial biopsy. Control participants will have history/exam, ECG, advanced echocardiography to rule out cardiac disease, and give blood and urine samples. Collected samples will be analyzed for total, misfolded, and fragmented transthyretin.

How the study is structured. Observational, cross-sectional cohort study. Participants have a single, thorough clinical assessment that may include medical history, physical exam, ECG, advanced echocardiography, cardiac magnetic resonance imaging (CMRI), blood and urine sampling, and quality-of-life questionnaires (KCCQ, EQ-5D-5L, and ATTR‑QoL). About 100 ATTRwt‑CM patients are included across disease stages; 20 healthy controls provide blood/urine and screening cardiac tests. A small subgroup (n≈10) may undergo endomyocardial biopsy.

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 Transthyretin Amyloidosis; Transthyretin Amyloid Cardiomyopathy; Wild-Type Transthyretin-Related (ATTR)Amyloidosis; Quality of Life. 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 Denmark. 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

This trial is also listed on this site under ATTRv 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
Feb 20, 2024
Primary completion
December 2025 (estimated)
Study completion
December 2025 (estimated)
Target enrollment
120 participants (estimated)
Last updated on registry
Aug 15, 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
Steen Hvitfeldt Poulsen
Collaborators
  • Novo Nordisk A/S

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 (1)

Terms used on this page · explanations by MedicalUpdates.ai

biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
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.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.

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.

← Back to clinical trials