Comparing sacubitril/valsartan and ramipril for heart failure treatment
The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction
This study tests whether a new heart medication called sacubitril/valsartan works better than ramipril for people with heart failure and a specific level of heart function.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 666 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 1 site (Krakow, Lesser Poland Voivodeship) |
| Trial ID | NCT05508035 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with symptomatic ischemic heart failure and left ventricular ejection fractions between 40-49%.
Not a fit: Patients with a history of hypersensitivity to the study drugs or those requiring simultaneous treatment with ACEI and ARB may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with heart failure and moderately reduced ejection fraction.
How similar studies have performed: While sacubitril/valsartan has shown success in patients with heart failure with reduced ejection fraction, its effectiveness in those with moderately reduced ejection fraction is still being evaluated, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Krakow, Lesser Poland Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.