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The Effect of Sacubitril/Valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients With Ischemic Heart Failure With Mid-range Ejection Fraction

RecruitingPhase 3Ages 18 Years - anyAllJohn Paul II Hospital, Krakow
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In plain words

What the trial is, and whether it could suit you

Heart failure with moderately reduced ejection fraction (HFmrEF) is a frequent disease associated with significant morbidity and mortality and therefore requires effective therapies that may improve clinical outcomes. The most common reason of HFmrEF is ischemic injury, usually caused by myocardial infarction, that may lead to left ventricular remodeling and systolic dysfunction, accompanied by symptoms of heart failure. Therefore, the anti-remodeling therapies may effectively improve clinical outcomes. Recently, sacubitril/valsartan - the angiotensin receptor neprilysin inhibitor suppressing the renin-angiotensin-aldosterone system and enhancing the effect of natriuretic peptides - has been introduced in the treatment of heart failure. To date, this drug was found to be clinically beneficial in patients with heart failure with reduced ejection fraction (HFrEF), however has not been test

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📋 Eligibility rules (as published)
Inclusion Criteria: * Written consent to participate in the study, expressed prior to any procedures related to the study. * Age 18 and over. * Symptomatic HF in NYHA class II to IV of ischemic etiology. * Left ventricular ejection fraction at screening visit ranged from 40-49%. * Elevated concentration of NT-proBNP natriuretic peptide ≥125 pg/ml. * Features of a structural / functional disease of the left ventricle. * Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated. Exclusion Criteria: * History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors. * Previous history of intolerance to recommended ACEI or ARB target doses. * Known history of angioedema. * Requirement of simultaneous treatment with ACEI and ARB. * Acute decompensated HF within 6 weeks prior to screening visit. * Symptomatic hypotension systolic blood pressure \<100 mmHg at screening visit. * Current or previous treatment with sacubitril / valsartan. * Estimated creatinine clearance \<30 ml / min / 1.73 m2 at screening visit. * Serum potassium \>5.2 mmol / L at screening visit. * Acute coronary syndrome or elective revascularization within 6 weeks prior to screening. * Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening. * Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI. * Fixed atrial fibrillation.
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What it tests

  • Sacubitril / Valsartan
  • Ramipril
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Where

1 site
Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
Krakow, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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