A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)

Prior treatment

• Has acute coronary syndrome, unstable angina, persistent angina at rest, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, cardiac valve repair (surgical or nonsurgical) or surgical replacement, or carotid angioplasty within 8 weeks prior to screening or during the Screening Period.

Other illness

• Has clinical suspicion of infiltrative cardiomyopathy (eg, amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.

Other

• Has evidence of recent HF exacerbation defined by hospitalization or requirement for intravenous (IV) or subcutaneous (SQ) diuretics within 4 weeks of the time of screening or during the Screening Period.
• Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration.
• Other protocol-defined criteria apply.

• Adult male or female patient ≥ 18 years of age (or adult age as per country guidelines) and ≤ 85 years of age at the time of screening.
• Has a medical history supporting a diagnosis of clinical chronic HF syndrome with a duration of at least 8 weeks prior to the time of screening and current NYHA functional class II to III (based on investigator’s assessment).
• Has left ventricular ejection fraction (EF) ≤ 40% by a centrally read transthoracic echocardiogram (TTE) performed during screening.
• Has N-terminal pro-B-type natriuretic peptide (NT-proBN) level ≥ 600 pg/mL (70.8 pmol/L) at the time of screening. Patients in atrial fibrillation or flutter at the time of screening are required to have an NT-proBNP level of ≥ 900 pg/mL (106.4 pmol/L).
• Is receiving optimized and stable guideline directed HF therapy (per applicable regional or national guidelines).
• Other protocol-defined criteria apply.