Can a new drug combo outperform standard care for a common type of heart failure?
NCT ID NCT05508035
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial is testing whether sacubitril/valsartan, a newer heart failure medication, can improve heart function and reduce harmful heart remodeling better than the older drug ramipril. The study enrolls adults with ischemic heart failure (caused by reduced blood flow to the heart) who have a moderately reduced ejection fraction (40-49%). Participants are randomly assigned to receive either sacubitril/valsartan or ramipril, and the main goal is to see if the newer drug leads to greater improvements in heart size and pumping ability over 12 months, as measured by MRI.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sacubitril/valsartan (a combination drug) compared against ramipril (an ACE inhibitor)
- What this could lead to
- If successful, this could establish sacubitril/valsartan as a better option than ramipril for improving heart function and preventing further damage in patients with ischemic heart failure with mid-range ejection fraction.
- What could go wrong
- This is a phase 3 trial, but results may not show a clear benefit over ramipril, and the drug may have side effects like low blood pressure or kidney issues. The outcome depends on long-term follow-up.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 488 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
RECRUITINGKrakow, Lesser Poland Voivodeship, 31-202, Poland
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