Investigating new biomarkers in cardiac transthyretin amyloidosis
Assessment of the Association of New Biomarkers (GDF15, ST2, Galectin-3, TIMP-1, MMP-9, NfL) and Plasma Prothrombotic Potential in the Course of Cardiac Transthyretin Amyloidosis
This study is testing new blood markers in people with transthyretin amyloidosis to see how they relate to heart failure and blood clot risks, including those who are carriers of the disease but don’t have symptoms yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 1 site (Kraków) |
| Trial ID | NCT06345235 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of new heart failure biomarkers in patients with transthyretin amyloidosis (ATTR), particularly focusing on asymptomatic carriers of pathogenic TTR variants. It will assess the prothrombotic potential associated with the disease, which may lead to increased thromboembolic complications. The study will include patients diagnosed with ATTR cardiomyopathy, asymptomatic carriers, and a control group of healthy volunteers, utilizing blood tests to gather relevant data. The findings could enhance understanding of the disease's pathology and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with ATTR cardiomyopathy, asymptomatic carriers of pathogenic TTR variants, or healthy volunteers without ATTR.
Not a fit: Patients under 18 years of age, those unable to provide informed consent, or pregnant and lactating women may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for patients with transthyretin amyloidosis.
How similar studies have performed: While there is limited published data on this specific approach, the exploration of biomarkers in cardiac amyloidosis is an emerging field with potential for significant insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: the study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3, n=20) 1. age over 18 2. expressing informed written consent 3. clinical criteria (one of the following for a given group): 1. ATTR cardiomyopathy (GROUP 1), 2. asymptomatic carrier of the pathogenic variant of the TTR gene (GROUP 2), 3. no diagnosed ATTR cardiomyopathy and no pathogenic variant of the TTR gene (GROUP 3). Exclusion criteria: 1. age under 18 years of age 2. failure to provide informed written consent 3. pregnancy and lactation Exclusion Criteria:
Where this trial is running
Kraków
- John Paul II Hospital — Kraków, Poland (Recruiting)
Study contacts
- Study coordinator: Katarzyna Holcman, MD
- Email: katarzyna.holcman@gmail.com
- Phone: 608214249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.