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CAMZYOS and placebo were administered orally, once a day. Dosage was monitored and adjusted (as needed) at weeks 8 and 14 to optimize patient response (decrease in LVOT gradient with Valsalva maneuver), maintain LVEF ≥50%, and was further informed by plasma concentrations of CAMZYOS
Study drug was discontinued and participants returned for key assessments at week 38
Primary composite functional endpoint measured change from baseline to week 30 in symptoms (NYHA) and functional
capacity (pVO2)1,2
HCMSQ-SoB=Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness of Breath subscore; KCCQ-23–CSS=Kansas City Cardiomyopathy Questionnaire
(23-item version) Clinical Summary Score; LVEF=left ventricle ejection fraction; LVOT=left ventricular outflow tract; NYHA=New York Heart Association; SRT=septal reduction therapy.
CAMZYOS (n=123) | Placebo (n=128) | |
---|---|---|
Age, mean (SD), years | 59 (12.2) | 59 (11.8) |
Women, n (%) | 57 (46) | 45 (35) |
Race, n (%) | ||
White Black or African American American Indian or Alaska Native Asian Unknown |
115 (94) 1 (1) 0 4 (3) 3 (2) |
114 (89) 5 (4) 1 (1) 2 (2) 6 (5) |
Background HCM treatment, n (%) |
||
Beta blocker Calcium channel blocker‡ |
94 (76) 25 (20) |
95 (74) 17 (13) |
NYHA class, n (%) | ||
Class II Class III |
88 (72) 35 (28) |
95 (74) 33 (26) |
pVO2 mean (SD), mL/kg/min | 18.9 (4.9) |
19.9 (4.9) |
LVOT gradient at baseline, mean (SD), mmHg |
||
Valsalva Post-exercise§ |
72 (32) 86 (34) |
74 (32) 84 (36) |
LVEF, mean (SD), (%) | 74 (6) | 74 (6) |
Critical cardiac history | ||
Atrial fibrillation, n (%) Implantable cardioverter- defibrillator, n (%) Prior invasive SRT, n (%) |
12 (10) 27 (22) 11 (9) |
23 (18) 29 (23) 8 (6) |
SD=standard deviation.
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