Obstructive Hypertrophic Cardiomyopathy
Conditions
Interventions
Case group:N/A
Sponsors
Chinese Academy of Medical Sciences Fuwai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese patients who are aged >= 18 years on the index date 2. Patients who have been diagnosed with oHCM on the index date 3. Patients have a LVEF >=55% recorded by echocardiography on or within 6 months prior to the index date 4. Patients have a documented NYHA functional class II–III or symptoms consistent with the NYHA functional class II–III on or within 6 months prior to the index date 5. Patients who have been hospitalized and administered Aficamten during hospitalization as part of their routine clinical care for oHCM on and after the index date. These patients are also: Receiving beta-blockers (BBs), non-dihydropyridine calcium channel blockers (non-DHP CCBs) or disopyramide for oHCM on the index date, OR to Receiving no treatments due to intolerance or failure of prior treatments for oHCM on the index date 6. Patients who are willing and able to provide written informed consent form before the start of this study
Exclusion criteria
Exclusion criteria: 1. Patients treated with any other investigational devices or drugs: They are participating or will participate in other interventional clinical trials on the index date, OR They completed other interventional clinical trials on the index date but received relevant treatments within one month (or 5 half-lives for drugs, whichever is longer) prior to the index date 2. Patients with severe non-cardiovascular diseases and whose life expectancy does not exceed 3 years, such as advanced cancer, kidney failure or any other end-stage diseases on the index date 3. Patients with severe cognitive impairment (e.g., Alzheimer's disease or dementia) or severe mental illness (e.g., schizophrenia or autism) on the index date 4. Female patients who are pregnant or in the lactation period on the index date 5. Patients who are receiving rifampin and are unable or not planning to discontinue rifampin on the index date 6. Patients with phenocopy diseases including Fabry disease, amyloidosis, glycogenosis, mitochondrial diseases, Friedreich's ataxia, hemochromatosis and dysmorphic syndromes, athlete’s heart or LV hypertrophy associated with hypertension on the index date 7. Patients who have a record of any fixed obstruction of the outflow tract such as aortic valve stenosis or replacement on the index date 8. Patients who have been successfully treated with invasive septal reduction therapy within 6 months prior to the index date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of newly diagnosed or worsening HF due to systolic dysfunction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the left ventricular outflow tract (LVOTG) at rest and after Valsalva;Cardiac Structural Parameters;Changes in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET);Changes in 6-minute walk test (6MWT);Changes in N terminal-pro B-type natriuretic peptide (NT-proBNP), B type natriuretic peptide (BNP) and high-sensitivity cardiac troponin I (hs-cTnI) measured by blood test;Changes in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) ;Improvements in the New York Heart Association (NYHA) functional class ;Incidence of left ventricular ejection fraction (LVEF) < 50% or incidence of LVEF < 40%;Incidence of adverse events (AEs), serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactLei Song
Chinese Academy of Medical Sciences Fuwai Hospital
Outcome results
None listed