A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)
A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
Inclusion Criteria:
Previous diagnosis of chronic heart failure (HF)
HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.
N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP
≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization
Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)
Left ventricular ejection fraction (LVEF) ≥45% and
Structural changes indicated by at least one of the following parameters:
NYHA class II or III at randomization
Exclusion Criteria:
Clinical instability at randomization, defined by
Use of IV inotropes at any time between qualifying HF event and randomization
Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization
Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
Complex congenital heart disease
Non-cardiac comorbidity (any of the following)
Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
San Nicolás de los Arroyos, Buenos Aires B2900DMH, Argentina
CABA, Ciudad Auton. de Buenos Aires C1426EGR, Argentina
Bad Oeynhausen, North Rhine-Westphalia 32545, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Kifisia / Athens, Attica 14561, Greece
Nea Ionia / Athens, 142 33, Greece
Zrifin, 7030000, Israel
Shinjuku-ku, Tokyo 162-8666, Japan
Kelantan, 15200, Malaysia
Sarawak, 94300, Malaysia
Santiago de Compostela, A Coruña 15706, Spain
Babio - Beade, Pontevedra 36312, Spain