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Compares treatment options for Heart Failure with Moderately Reduced Ejection Fraction
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
ClinicalTrials.gov ID: NCT05508035
What this study is testing
What is Sacubitril / Valsartan?
Sacubitril / Valsartan is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for heart failure with moderately reduced ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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.
- Left ventricular ejection fraction at screening visit ranged from 40-49%.
- Elevated concentration of NT-proBNP natriuretic peptide ≥125 pg/ml.
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.
- 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.
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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Krakow, Lesser Poland Voivodeship, Poland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Krakow, Lesser Poland Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.