Phenotyping and Characterization of wtATTR-CM (TRACE 1)

Launched by STEEN HVITFELDT POULSEN · Feb 26, 2024

Keywords

ClinConnect Summary

The TRACE 1 clinical trial is studying a condition called wild-type transthyretin amyloidosis with cardiomyopathy (ATTRwt-CM), which affects the heart and can impact patients' quality of life. The trial aims to understand how the severity of this condition affects patients' everyday lives and to explore whether certain proteins in the blood and urine are linked to the severity of the disease. Researchers will be looking at 100 participants who have been diagnosed with ATTRwt-CM to gather this information.

To join the study, participants must be adults over 18 years old who have a confirmed diagnosis of ATTRwt-CM. This includes having specific tests done, like a biopsy or imaging scans. Unfortunately, people with other types of amyloidosis or certain heart conditions can't participate. Those who join the trial can expect to provide consent and share information about their health and quality of life. This research could help improve understanding of ATTRwt-CM and potentially lead to better care for patients in the future.

Gender

ALL

Eligibility criteria

• • Group 1: wtATTR-CM patients
• Inclusion Criteria:
• * 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
• Inclusion Criteria:
• • Patients \> 18 years
• • Informed oral and written consent
• Exclusion Criteria:
• • 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