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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518239-12-00
Acronym
DW.0701.005.2020P
Enrollment
666
Registered
2024-12-16
Start date
2023-01-26
Completion date
Unknown
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure with moderately reduced ejection fraction (HFmrEF)

Brief summary

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

Detailed description

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., All-cause death in patients with ischemic HFmrEF over a 12 month treatment period.

Interventions

DRUGRAMIPRIL
DRUGPlacebo to VALSARTAN AND SACUBITRIL PL1 PL2
DRUGPlacebo to RAMIPRIL PL3 PL4

Sponsors

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026