NCT06251778 NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis
| NCT ID | NCT06251778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paolo Milani |
| Condition | Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2027-01-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-01-26 with a primary completion date of 2027-01-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
All ATTRwt patients on tafamidis 61 mg treatment will be clinically evaluated before treatment initiation and subsequently every six months for the eligibility to continue tafamidis treatment, according to Italian Medicines Agency regulations. C onsidering the significant risk of developing heart rhythm disturbances due to cardiac amyloidosis, especially in transthyretin form (ATTRwt), in routine clinical practice a stricter heart rhythm monitoring is recommended in ATTRwt patients. Moreover, particular attention is usually paid for those who present atrio-ventricular and/or intraventricular block at the baseline electrocardiogram. Data about rhythm disturbances and diuretic dose need will be collected during the planned physical examination every six months and the Holter ECG monitoring requested by the physician at the end of every planned clinical evaluation.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of ATTRwt amyloidosis. * 18 years or older; * evidence of cardiac involvement at echocardiography or cardiac MRI. * No known prior history of atrial fibrillation or major bradyarrhythmia (second degree atrioventricular block, third-degree atrioventricular block, high-grade atrioventricular block or alternating right and left branch block) * female patients who are postmenopausal for at least 1 year before the screening visit * patients on therapy or candidates for therapy with tafamidis 61 mg * voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. Exclusion Criteria: * Non-ATTR amyloidosis; * NYHA class III and IV; * Pregnant or nursing women; * Previous pacemaker implantation; * any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a fully comprehension of the written consent form
Frequently Asked Questions
Who can join the NCT06251778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06251778 currently recruiting?
Yes, NCT06251778 is actively recruiting participants. Visit ClinicalTrials.gov or contact Paolo Milani to inquire about joining.
Where is the NCT06251778 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06251778 clinical trial?
NCT06251778 is sponsored by Paolo Milani. The trial plans to enroll 200 participants.