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

Launched by JOHN PAUL II HOSPITAL, KRAKOW · Aug 18, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of two different medications—sacubitril/valsartan and ramipril—on heart function in patients who have a specific type of heart failure called ischemic heart failure with mid-range ejection fraction (HFmrEF). This condition often arises after heart injuries, like a heart attack, leading to changes in the heart's structure and function. The goal of the study is to see if sacubitril/valsartan can help improve heart function and prevent further damage compared to ramipril, a commonly used heart medication.

To participate in the study, individuals must be at least 18 years old, have symptoms of heart failure, and have a left ventricular ejection fraction (a measure of how well the heart pumps blood) between 40-49%. They should also have elevated levels of a specific heart-related substance in their blood. Participants will first take ramipril to establish a baseline before being randomly assigned to take either ramipril or sacubitril/valsartan for 12 months. Throughout the study, researchers will monitor changes in heart size and function, as well as track any serious heart-related events. This trial could provide valuable insights into new treatment options for patients with this type of heart failure.

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Eligibility criteria

• 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.