Cardiomyopathy Trial, Recruiting NCT06291805 Sponsor: Steen Hvitfeldt Poulsen Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT06291805
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Group 1 – People with a specific type of heart condition called wild-type ATTR cardiac amyloidosis (wtATTR-CM):

  • Adults over 18 years old who have been diagnosed with wtATTR-CM, either through a small tissue sample taken from the heart (endomyocardial biopsy), or through a specific nuclear medicine scan (DPD scintigraphy) showing a certain level of protein buildup, combined with genetic testing that rules out an inherited form of the disease
  • People who have given their agreement to take part, both verbally and in writing

Group 2 – Healthy comparison (control) group:

  • Adults over 18 years old
  • People who have given their agreement to take part, both verbally and in writing

Who may not be able to join:

Group 1 – People with wtATTR-CM:

  • People who have a different type of amyloidosis caused by abnormal proteins from blood cells (AL amyloidosis or light-chain amyloidosis)
  • People who have a type of blood cancer affecting plasma cells (myeloma)
  • People who have a condition involving abnormal white blood cells that produce excess protein (Waldenström macroglobulinemia)

Group 2 – Control group:

  • People who have a known heart or cardiovascular condition, including blocked heart arteries, heart failure, an irregular heartbeat called atrial fibrillation, a pacemaker, or severely uncontrolled high blood pressure (well-controlled high blood pressure is generally acceptable)
  • People where there is a suspicion of cardiac amyloidosis (protein buildup in the heart) based on any of the following warning signs:
    • Heart wall thickening seen on ultrasound (septum greater than 11mm)
    • A particular pattern of reduced heart muscle movement seen on heart ultrasound (apical sparing on LV-GLS) (confirm with trial site)
    • Thickening of certain heart structures seen on ultrasound, including the right side of the heart wall, heart valves between chambers, or the wall between the upper chambers
    • Symptoms suggesting nerve damage in the hands or feet (polyneuropathy)
    • An abnormal electrical heart tracing (ECG) showing unusually low signals, or a mismatch between heart wall thickness and ECG readings
    • A slowed electrical signal between the upper and lower chambers of the heart (AV block)
    • Carpal tunnel syndrome affecting both wrists
    • Previous surgery for spinal stenosis (narrowing of the spinal canal)
    • Elevated levels of certain proteins in the blood that can indicate heart stress (troponin I or NT-pro-BNP)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +45 30 48 88 85

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Steen Hvitfeldt Poulsen
Registry
ClinicalTrials.gov
Start date
20 February 2024
Est. completion
1 December 2025

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Investigation of cardiac amyloidosis severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy.; Investigation of the relations between cardiac amyloid severity and patient quality of life in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy.; Assessment of transthyretin and pathogenic fragments and relation to cardiac amyloid severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov