Evaluation of heart health in patients with ATTR amyloidosis on tafamidis treatment
NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis: Real World Prospective Study
This study looks at how tafamidis treatment affects heart health in patients with ATTR amyloidosis by checking their heart rhythm and other health needs every six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06251778 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with transthyretin amyloid cardiomyopathy (ATTRwt) who are receiving tafamidis treatment. Participants will undergo clinical evaluations before starting treatment and every six months thereafter to monitor their eligibility for continued therapy. The study emphasizes the importance of heart rhythm monitoring due to the risk of disturbances associated with cardiac amyloidosis. Data on rhythm disturbances and diuretic needs will be collected during these evaluations, along with Holter ECG monitoring as required by the physician.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with ATTRwt amyloidosis who show evidence of cardiac involvement.
Not a fit: Patients with non-ATTR amyloidosis or those with severe heart failure (NYHA class III and IV) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management and monitoring of heart health in patients with ATTR amyloidosis, potentially improving treatment outcomes.
How similar studies have performed: While this approach is focused on monitoring and management, similar studies have shown promise in improving outcomes for patients with cardiac amyloidosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
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.