heart failure with moderately reduced ejection fraction (HFmrEF) MedDRA version: 20.0 Level: LLT Classification code 10010684 Term: Congestive heart failure System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Entresto 49 mg/51 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sacubitril
CAS Number: 149709-62-6
Other descriptive name: DB09292 – Drug Bank
Concent
Sponsors
John Paul II Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written consent to participate in the study, expressed prior to any procedures related to the study. 2. Age 18 and over. 3. Symptomatic HF in NYHA class II to IV of ischemic etiology at screening visit. 4. Left ventricular ejection fraction at screening visit ranged from 40-49%, confirmed by echocardiography at a randomization visit. 5. Elevated concentration of NT-proBNP natriuretic peptide=125 pg / ml at screening visit(if sinus rhythm during the visit). 6. Elevated NT-proBNP natriuretic peptide concentration=350 pg/ml at the screening visit (if atrial fibrillation or flutter during the visit). 7. Features of a structural / functional disease of the left ventricle. 8. Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated. 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 466
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors. 2. Previous history of intolerance to recommended ACEI or ARB target doses. 3. Known history of angioedema. 4. Requirement of simultaneous treatment with ACEI and ARB. 5. Acute decompensated HF within 6 weeks prior to screening visit. 6. Symptomatic hypotension systolic blood pressure 5.2 mmol / L at screening visit. 10. Acute coronary syndrome or elective revascularization within 6 weeks prior to screening. 11. Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening. 12. Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to evaluate the effect of sacubitril / valsartan versus ramipril on left ventricular remodeling and function in ischemic HFmrEF patients. The primary objective of the study is to evaluate the effect of sacubitril / valsartan versus ramipril on the change in left ventricular end-systolic volume as measured by magnetic resonance imaging (MRI) in patients with ischemic HFmrEF after 12 months of treatment.;Secondary Objective: Assessment of the effect of sacubitril / valsartan compared to ramipril on 1. change in left ventricular end-diastolic volume measured by MRI 2. change in indexed left ventricular end-systolic and end-diastolic volumes measured by MRI 3. change in left ventricular ejection fraction measured by MRI 4. occurrence of the endpoint of death from cardiovascular causes or first hospitalization for HF 5. the occurrence of the endpoint of death from cardiovascular causes or first or subsequent hospitalization for HF 6. occurrence of death from cardiovascular causes 7. first hospitalization due to HF 8. occurrence of the first or subsequent hospitalization due to HF 9. time to death from cardiovascular causes or first hospitalization for HF 10. occurrence of death from any cause in patients with ischemic HFmrEF over a 12 month treatment period.;Primary end point(s): Change in left ventricular end-systolic volume after 12 months of treatment as measured by MRI.;Timepoint(s) of evaluation of this end point: Randomization visit (W4) and final visit (W9, 12 months after randomization visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in left ventricular end-diastolic volume measured by MRI in patients with ischemic HFmrEF after 12 months of treatment. 2. Change in indexed left ventricular end-systolic and end-diastolic volumes measured by MRI in patients with ischemic HFmrEF after 12 months of treatment. 3. Change in left ventricular ejection fraction measured by MRI in patients with ischemic HFmrEF after 12 months of treatment. 4. Death from cardiovascular causes or first hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period. 5. Death from cardiovascular causes or first or subsequent hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period. 6. Death from cardiovascular causes in patients with ischemic HFmrEF over a 12 month treatment period. 7. First hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period. 8. First or subsequent hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period. 9. Number of days until death from cardiovascular causes or first hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period. 10. All-cause death in patients with ischemic HFmrEF over a 12 month treatment period. Endpoints in the safety assessment: 1. Development of symptomatic hypotension or with systolic blood pressure 5.4 mmol / L. 3. Development of renal failure with eGFR <30 ml / min / 1.73 m2 or exacerbation of renal failure with eGFR decrease compared to visit W1 or W2 by more than 25%.;Timepoint(s) of evaluation of this end point: Endpoints 1-3 - at randomization visit (W4) and final visit (W9, 12 months after randomization visit) Endpoints 4-10 - throughout the whole study period Endpoints in the safety assessment - at all visits except the screening visit | — |
Countries
Poland
Contacts
Public ContactStudy Coordinator
Jadwiga Nessler
Outcome results
None listed