Valsartan; Sacubitril for Ischemic heart failure with mid-range ejection fraction (HFmrEF)

Inclusion criteria

• {"criterion_text":"- Written consent to participate in the study, expressed prior to any procedures related to the study."}
• {"criterion_text":"- Age 18 and over."}
• {"criterion_text":"- Symptomatic HF in NYHA class II to IV of ischemic etiology at screening visit."}
• {"criterion_text":"- Left ventricular ejection fraction at screening visit ranged from 40- 49%, confirmed by echocardiography at a randomization visit."}
• {"criterion_text":"- Elevated concentration of NT-proBNP natriuretic peptide≥125 pg / ml at screening visit(if sinus rhythm during the visit)."}
• {"criterion_text":"- Elevated NT-proBNP natriuretic peptide concentration≥350 pg/ml at the screening visit (if atrial fibrillation or flutter during the visit)."}
• {"criterion_text":"- Features of a structural / functional disease of the left ventricle."}
• {"criterion_text":"- Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated."}

Exclusion criteria

• {"criterion_text":"- History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors."}
• {"criterion_text":"- Acute coronary syndrome or elective revascularization within 6 weeks prior to screening."}
• {"criterion_text":"- Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening."}
• {"criterion_text":"- Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI."}
• {"criterion_text":"- Previous history of intolerance to recommended ACEI or ARB target doses."}
• {"criterion_text":"- Known history of angioedema."}
• {"criterion_text":"- Requirement of simultaneous treatment with ACEI and ARB."}
• {"criterion_text":"- Acute decompensated HF within 6 weeks prior to screening visit."}
• {"criterion_text":"- Symptomatic hypotension systolic blood pressure <95 mmHg at screening visit."}
• {"criterion_text":"- Current or previous treatment with sacubitril / valsartan not related to participation in the clinical trial."}
• {"criterion_text":"- Estimated creatinine clearance <30 ml / min / 1,73 m2 at screening visit."}
• {"criterion_text":"- Serum potassium >5.2 mmol / L at screening visit."}

Primary endpoints

• {"endpoint_text":"- Change in left ventricular end-systolic volume after 12 months of treatment as measured by MRI.","definition_or_measurement_approach":"Change from baseline in left ventricular end-systolic volume measured by magnetic resonance imaging (MRI) after 12 months of treatment."}

Secondary endpoints

• {"endpoint_text":"- Change in left ventricular end-diastolic volume measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.","definition_or_measurement_approach":"Change from baseline in LV end-diastolic volume measured by MRI after 12 months."}
• {"endpoint_text":"- Change in indexed left ventricular end-systolic and end-diastolic volumes measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.","definition_or_measurement_approach":"Change from baseline in indexed LV end-systolic and end-diastolic volumes measured by MRI after 12 months."}
• {"endpoint_text":"- Change in left ventricular ejection fraction measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.","definition_or_measurement_approach":"Change from baseline in left ventricular ejection fraction measured by MRI after 12 months."}
• {"endpoint_text":"- Death from cardiovascular causes or first hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"Composite clinical endpoint: death from cardiovascular causes or first hospitalization for heart failure assessed over 12 months."}
• {"endpoint_text":"- Death from cardiovascular causes or first or subsequent hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"Composite clinical endpoint: death from cardiovascular causes or first or subsequent hospitalization for HF assessed over 12 months."}
• {"endpoint_text":"- Death from cardiovascular causes in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"Death from cardiovascular causes assessed over 12 months."}
• {"endpoint_text":"- First hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"First hospitalization for heart failure assessed over 12 months."}
• {"endpoint_text":"- First or subsequent hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"First or subsequent hospitalizations for HF assessed over 12 months."}
• {"endpoint_text":"- Number of days until death from cardiovascular causes or first hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"Time (days) from randomization to death from cardiovascular causes or first hospitalization for HF within 12 months."}
• {"endpoint_text":"- All-cause death in patients with ischemic HFmrEF over a 12 month treatment period.","definition_or_measurement_approach":"All-cause mortality assessed over 12 months."}

Poland

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

16-12-2024

Processing Time Days

49

Number Of Sites

6

Number Of Participants

666

Primary sponsor

Full Name

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"50Bio.Com Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1,12,5","organisation_type":"Pharmaceutical company"}