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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.
EU CTIS ID: 2024-518239-12-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 at screening visit.
- Left ventricular ejection fraction at screening visit ranged from 40- 49%, confirmed by echocardiography at a randomization visit.
- Elevated concentration of NT-proBNP natriuretic peptide≥125 pg / ml at screening visit(if sinus rhythm during the visit).
- Elevated NT-proBNP natriuretic peptide concentration≥350 pg/ml at the screening visit (if atrial fibrillation or flutter during the visit).
You likely can't join if
- History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors.
- 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.
- Previous history of intolerance to recommended ACEI or ARB target doses.
- Known history of angioedema.
See the full eligibility 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 at screening visit.
- Left ventricular ejection fraction at screening visit ranged from 40- 49%, confirmed by echocardiography at a randomization visit.
- Elevated concentration of NT-proBNP natriuretic peptide≥125 pg / ml at screening visit(if sinus rhythm during the visit).
- Elevated NT-proBNP natriuretic peptide concentration≥350 pg/ml at the screening visit (if atrial fibrillation or flutter during the visit).
- Features of a structural / functional disease of the left ventricle.
- Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated.
- History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors.
- 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.
- 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 <95 mmHg at screening visit.
- Current or previous treatment with sacubitril / valsartan not related to participation in the clinical trial.
- Estimated creatinine clearance <30 ml / min / 1,73 m2 at screening visit.
- Serum potassium >5.2 mmol / L at screening visit.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.