Comparing sacubitril/valsartan and ramipril for heart failure treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of sacubitril/valsartan compared to ramipril in patients with ischemic heart failure and moderately reduced ejection fraction. The study focuses on patients who have symptomatic heart failure and left ventricular ejection fractions between 40-49%. By assessing the impact of these medications on left ventricular function and remodeling, the trial aims to identify potential improvements in clinical outcomes for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
  Krakow, Lesser Poland Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Jadwiga Nessler, professor
• Email: badaniakliniczne@szpitaljp2.krakow.pl
• Phone: +48 12 6142218

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Diet and exercise plan to help people with heart failure and preserved heart function.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.