Heart Disease
IONIS
To evaluate a new medication for the treatment of patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM).
Trial overview
Topic
Cardiovascular disease
Eligibility criteria
To be considered for the study you must meet the following criteria:
- Aged between 18 to 90 years of age
- End-diastolic interventricular septum thickness of > 12 mm on Screening echocardiogram
- Medical history of HF secondary with at least:
- Prior hospitalization for HF, which may include hospitalization for arrhythmia or pacemaker/ICD (implantable cardioverter defibrillator) placement, OR
- Symptoms and signs of volume overload or elevated intracardiac pressure that requires treatment with diuretics other than mineralocorticoid receptor antagonists (MRA) for clinical stabilization
- New York Heart Association (NYHA) class I-III
Study details
Your participation in this study would be for approximately 3 years.
You are required to attending a screening period lasting up to 10 weeks, then If eligible, you will receive an under the skin injection every 4 weeks from week 1 through to week 117, totaling 30 injections. In addition to this you will be required to take a Vitamin A supplement for the duration of the trial.
You will then be followed up with an in clinic at the end of the treatment (4 weeks after last dose).
You will be reimbursed for travel and study related expenses.
Further information
For more information on this clinical trial here.
Location