Evaluation of heart health in patients with ATTR amyloidosis on tafamidis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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 it's running

• Fondazione IRCCS Policlinico San Matteo
  Pavia, Italy Recruiting

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.