Actively Recruiting
The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction
Led by John Paul II Hospital, Krakow · Updated on 2024-10-31
666
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 tested in the group of patients with HFmrEF. The aim of the study is to evaluate effectiveness of sacubitril/valsartan as compared with ramipril on left ventricular remodeling and function in patients with ischemic HFmrEF. Patients with ischemic HFmrEF, New York Heart Association class II-IV symptoms, an elevated plasma natriuretic peptide level and the left ventricular ejection fraction (LVEF) of 40-49 % will be enrolled in this prospective, multicenter, randomized, double-blind, active-controlled study. Initially, patients will enter a single-blind ramipril run-in period (titrated to 5 mg bid), followed by a sacubitril/valsartan run-in period (100 mg titrated to 200 mg bid). A total of 666 patients tolerating both periods will be randomized 1:1 to either ramipril 10 mg bid or sacubitril/valsartan 200 mg bid. The primary endpoint will be the change of left ventricular end-systolic volume index within 12-month of treatment as measured by magnetic resonance imaging. The main secondary endpoints include the change of left ventricular end-diastolic volume index within 12-month of treatment, the change of LVEF within 12-month of treatment, 12-month composite endpoint of cardiovascular death or heart failure requiring hospitalization, 12-month cardiovascular death, 12-month heart failure requiring hospitalization, time to death or heart failure requiring hospitalization or mortality rate within 12-month of treatment. This study may determine the place of sacubitril/valsartan as an alternative to ramipril in the treatment of patients with ischemic HFmrEF in order to prevent further left ventricular remodeling and to improve its systolic function.
CONDITIONS
Official Title
The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent to participate in the study, expressed prior to any procedures related to the study.
- Age 18 and over.
- Symptomatic heart failure in New York Heart Association class II to IV of ischemic cause.
- Left ventricular ejection fraction between 40% and 49% at screening.
- Elevated NT-proBNP natriuretic peptide concentration of at least 125 pg/ml.
- Signs of structural or functional disease of the left ventricle.
- Receiving optimal treatment with ACE inhibitors or angiotensin receptor blockers and beta-blockers, unless these are contraindicated.
You will not qualify if you...
- History of allergy or hypersensitivity to the study drugs or similar drugs, ACE inhibitors, angiotensin receptor blockers, or neprilysin inhibitors.
- Previous intolerance to recommended doses of ACE inhibitors or angiotensin receptor blockers.
- Known history of angioedema.
- Need for simultaneous treatment with both ACE inhibitors and angiotensin receptor blockers.
- Acute worsening of heart failure within 6 weeks before screening.
- Symptomatic low blood pressure with systolic pressure below 100 mmHg at screening.
- Current or past treatment with sacubitril/valsartan.
- Estimated creatinine clearance below 30 ml/min/1.73 m2 at screening.
- Serum potassium level over 5.2 mmol/L at screening.
- Acute heart event or planned revascularization within 6 weeks before screening.
- Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or other major heart surgery within 3 months before screening.
- Implanted defibrillator, pacemaker, or resynchronization device incompatible with MRI.
- Permanent atrial fibrillation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
Krakow, Lesser Poland Voivodeship, Poland, 31-202
Actively Recruiting
Research Team
J
Jadwiga Nessler, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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