Effect of Vericiguat on cardiAc Remodeling in Patients With Heart faiLure and Reduced Ejection fractioN (HFrEF): A Prospective sTudy usIng NOvel Echocardiographic Imaging Techniques (VALENTINO)

Inclusion Criteria

• •Age ≥ 18y
• •Chronic HF; New York Heart Association (NYHA) class II-III, LVEF ≤40% (recent 12 months), and on guideline-directed heart failure therapy
• •Recent (6 months) heart failure hospitalization or intravenous diuretic use (without hospitalization) within 3 months
• •Elevated NT-proBNP 1000-6000 pg/ml (1600-6000 pg/ml if atrial fibrillation) within 30 days
• •Clinically stable (systolic blood pressure ≥100 mm Hg and no intravenous diuretics for 48 hours)
• •Meet one of the following criteria:
• •a. Male
• •b. Female who is not of reproductive potential, defined as a female who either: (1) postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing
• •c. Female who is of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity, OR (2) use (or have her partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are:
• •i. Single method (one of the following is acceptable):
• •• Intrauterine device, vasectomy of a female subject's male partner, or contraceptive rod implanted into the skin
• •ii. Combination method (use of two of the following)
• •• Diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male condom or female condom, or hormonal contraceptive