Heart failure and preserved ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Previous diagnosis of chronic 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: ? Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness =1.1 cm, and/or LV mass index =115 g/m2 in male and =95 g/m2 in female), or ? Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index =29 ml/m2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm2, or LA diameter >40 mm in male and >38 mm in female patients) - NYHA class II or III at randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 585
Exclusion criteria
Exclusion criteria: - Clinical instability at randomization, defined by o Any IV treatment within 24h prior to randomization, and/or o SBP =160 mmHg o SBP 45 kg/m2 o Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment o Requires continuous home oxygen for severe pulmonary disease or has interstitial lung disease o Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients - Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of vericiguat 10 mg in comparison to placebo on improving physical functioning from baseline to week 24. To evaluate the efficacy of vericiguat 15 mg in comparison to placebo on improving physical functioning from baseline to week 24. ;Secondary Objective: To evaluate the efficacy of vericiguat 10 mg/ 15 mg in comparison to placebo on improving distance traveled on a 6-minute walk test (6MWT) from baseline to week 24 To evaluate the efficacy of vericiguat 10 mg/ 15 mg in comparison to placebo in increasing the proportion of patients with Kansas City Cardiomyopathy Questionnaire (KCCQ) physical limitation score (PLS) improvement from baseline by >5 points at 24 weeks and other thresholds (e.g. >3, >7, >10, >15, >20), and the proportions with these improvements in the other KCCQ domains; overall symptom score (OSS), clinical summary score (CSS), total symptom score (TSS) and symptom frequency score (SFS). To evaluate the efficacy of vericiguat 10 mg/ 15 mg in comparison to placebo in decreasing the proportion of patients with KCCQ PLS decline from baseline by >5 points at 24 weeks and the proportions with decline in the other KCCQ domains OSS, CSS, TSS and SFS.;Primary end point(s): - Change in KCCQ PLS from baseline to week 24;Timepoint(s) of evaluation of this end point: - From baseline to week 24 - From signing of informed consent to safety follow-up (at 28 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the 6 MWT from baseline to week 24 ;Timepoint(s) of evaluation of this end point: From baseline to week 24 | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Poland, Portugal, Russian Federation, Serbia, Singapore, South Africa, Spain, Taiwan, United States
Contacts
Public ContactClinical Trials Contact
Bayer AG
Outcome results
None listed