IRB Study Number 22-726
Status Recruiting
Phase Not Applicable
Institute Heart and Vascular Institute
Description
This is an observational, multicenter registry of prospectively enrolled adult patients with symptomatic (New York Heart Association [NYHA] functional class II-IV) obstructive HCM in the United States (US) and Puerto Rico and LVEF >55% at enrollment. The purpose of this research study is to understand the treatment patterns and effects of FDA approved therapies including mavacamten (a recently FDA approved medication to treat obstructive HCM). This study will also evaluate the effects of various medications on heart failure caused by obstructive HCM, any side effects that might occur, and the impact to quality of life when taking these medications. Data will be collected up to 5 years prior to enrollment and up to 5 years into the future from the patient medical record. There is also an optional blood draw sub study which would require on site visits every 3 months.
Inclusion Criteria
1) Diagnosis of obstructive HCM
2) ≥18 years of age at the time of informed consent
3) Receiving treatment for obstructive HCM
Exclusion Criteria
1) Surgical intervention for obstructive HCM within the last 6 months
2) Never been treated for obstructive HCM
3) Receiving an investigational therapeutic agent for obstructive HCM in an interventional clinical trial at patient enrollment