Chronic heart failure NYHA class II-IV with reduced ejection fraction (EF =< 40%) and elevated NT-proBNP = 600 pg/mL, but 400 pg/mL if hospitalized for heart failure within 12 months
Conditions
Interventions
Trade Name: Entresto
Product Name: Entresto
Product Code: LCZ696
Pharmaceutical Form: Tablet
INN or Proposed INN: Sacubitril
CAS Number: 149709-62-6
Other descriptive name: sacubitril
Concentration un
Sponsors
FIMABIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must give written informed consent before any assessment is performed. - Outpatients = 18 years of age, male or female. -Diagnosis of chronic heart failure NYHA class II-IV with reduced ejection fraction (EF ==65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: - History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or neprilysin inhibitors as well as known or suspected contraindications to the study drugs. - Previous history of intolerance to recommended target doses of ACEIs or ARBs. - Known history of angioedema. - Requirement of treatment with both ACEIs and ARBs - Current acute decompensated heart failure (exacerbation of chronic heart failure manifested by signs and symptoms that may require intravenous therapy). - Symptomatic hypotension and/or a SBP 5.2 mmol/L. - Participation in clinical trial with another drug within 30 days of first study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To describe the effect of LCZ696 on left ventricular remodeling and myocardial fibrosis assessed by cardiac magnetic resonance in heart failure patients with reduced ejection fraction and high comorbidity;Secondary Objective: - To describe the effect of LCZ696 on left ventricular remodeling and myocardial fibrosis assessed by novel heart failure biomarker (soluble ST2) in heart failure patients with reduced ejection fraction and high comorbidity. - To assess correlation of novel HF Biomarker with Soc HF biomarkers. - To describe the effect of LCZ696 on left ventricular remodeling and myocardial fibrosis assessed by variation from baseline in % of fibrosis and LV Volume;Primary end point(s): - Variation of myocardial fibrosis assessed by changes (from basal to month 12 visit) in quantification of mass of myocardial fibrosis, as identified by delayed contrast-enhancement in cardiac MRI.;Timepoint(s) of evaluation of this end point: Base line and after 12 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Assessment of change from baseline in heart failure biomarkers: soluble ST2. Correlation with change in fibrosis as assessed by cardiac MRI. - Assessment of change from baseline in SoC heart failure biomarkers: (N- terminal pro-B-type natriuretic peptide and highly-sensitive troponin). Correlation with change assessed with novel biomarker. - Variation from baseline in percentage (%) of myocardial fibrosis and LV Volume according to total myocardium assessed by cardiac magnetic resonance.;Timepoint(s) of evaluation of this end point: First two endpoints timepoint's: Baseline, 3, 6,9 and 12 months after treatment Third endpoint: Baseline and after 12 months treatment | — |
Countries
Spain
Contacts
Public ContactClinical Trial Platform
FIMABIS
Outcome results
None listed