The effect of sacubitril/valsartan versus ramipril on left ventricular function and remodeling in patients with ischemic heart failure with mid-range ejection fraction.

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II6 sites in 1 country666 target enrollmentDecember 16, 2024

DrugsPlacebo to RAMIPRIL PL3 PL4 VALSARTAN AND SACUBITRIL Placebo to VALSARTAN AND SACUBITRIL PL1 PL2 RAMIPRIL AHU377

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Enrollment: 666
Locations: 6
Primary Endpoint: Change in left ventricular end-systolic volume after 12 months of treatment as measured by MRI.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the effect of sacubitril / valsartan versus ramipril on left ventricular remodeling and function in ischemic HFmrEF patients. The primary objective of the study is to evaluate the effect of sacubitril / valsartan versus ramipril on the change in left ventricular end-systolic volume as measured by magnetic resonance imaging (MRI) in patients with ischemic HFmrEF after 12 months of treatment.

Registry

euclinicaltrials.eu

Start Date

December 16, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II

Responsible Party

Principal Investigator

Co-ordinating Investigator

Scientific

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II

Eligibility 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 at screening visit.
•Left ventricular ejection fraction at screening visit ranged from 40- 49%, confirmed by echocardiography at a randomization visit.
•Elevated concentration of NT-proBNP natriuretic peptide≥125 pg / ml at screening visit(if sinus rhythm during the visit).
•Elevated NT-proBNP natriuretic peptide concentration≥350 pg/ml at the screening visit (if atrial fibrillation or flutter during the visit).
•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.
•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.
•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 <95 mmHg at screening visit.
•Current or previous treatment with sacubitril / valsartan not related to participation in the clinical trial.

Outcomes

Primary Outcomes

Change in left ventricular end-systolic volume after 12 months of treatment as measured by MRI.

Secondary Outcomes

All-cause death in patients with ischemic HFmrEF over a 12 month treatment period.
Change in left ventricular end-diastolic volume measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.
Change in indexed left ventricular end-systolic and end-diastolic volumes measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.
Change in left ventricular ejection fraction measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.
Death from cardiovascular causes or first hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period.
Death from cardiovascular causes or first or subsequent hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period.
Death from cardiovascular causes in patients with ischemic HFmrEF over a 12 month treatment period.
First hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.
First or subsequent hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.
Number of days until death from cardiovascular causes or first hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.