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Pulmonary REsistance modification under treatment with Sacubitil/valsartaN in paTients with HeartFailure with reduced ejection fraction

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517975-19-00
Acronym
2019/ABM/01/00078
Enrollment
32
Registered
2024-12-18
Start date
2022-12-12
Completion date
2025-07-18
Last updated
2024-12-18

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

Conditions

Heart Failure with reduced ejection fraction.

Brief summary

Change from baseline in mean pulmonary artery pressure (mPAP)., Change from baseline in pulmonary vascular resistance (PVR).

Detailed description

Change from baseline in pulmonary wedge pressure (PWP)., Change from baseline in the diastolic pressure gradient (DPG; where DPG = diastolic mPAP – mean PWP )., Change in the 6-minute walk test (6MWT) - analysis of changes from the baseline., Evaluation of the parameters of the spiroergometric test (CPET, Cardio-Pulmonary Exercise Test) analysis of changes in relation to the baseline., Assessment of echocardiographic parameters - analysis of changes in relation to the baseline, The incidence of the composite endpoint of MACCEs such as death from all causes, cardiac death, hospitalization due to worsening / decompensation of HF, stroke / transient ischemic attack (TIA), acute coronary syndrome (ACS) , the need for a heart transplant (HT), the need for a left ventricular assist device (LVAD) or biventricular , an unplanned hospitalization or an outpatient visit due to the need to administer intravenous diuretics or requiring an increase in the dose of diuretics >50% base, Hospitalization or an unplanned visit to the Emergency Department or an unplanned outpatient visit related to HF, The need for unplanned intravenous administration of diuretics., Assessment of quality of life will be conducted between 0-52 weeks (QoL indicators - Kansas City Cardiomyopathy Questionnaire (KCCQ-12), WHO (WHOQOL-BREF), SF-36 questionnaire, EQ-5D-3L questionnaire) - change from the baseline, Assessment of the New York Heart Association (NYHA) and the World Health Organization (WHO) functional classes - change from the baseline

Interventions

DRUGPlacebo Entresto 24mg/26mg
DRUGEnalapril-ratiopharm® 2
DRUGPlacebo Enalapril 2
DRUG5 mg

Sponsors

Uniwersytecki Szpital Kliniczny W Poznaniu
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in mean pulmonary artery pressure (mPAP)., Change from baseline in pulmonary vascular resistance (PVR).

Secondary

MeasureTime frame
Change from baseline in pulmonary wedge pressure (PWP)., Change from baseline in the diastolic pressure gradient (DPG; where DPG = diastolic mPAP – mean PWP )., Change in the 6-minute walk test (6MWT) - analysis of changes from the baseline., Evaluation of the parameters of the spiroergometric test (CPET, Cardio-Pulmonary Exercise Test) analysis of changes in relation to the baseline., Assessment of echocardiographic parameters - analysis of changes in relation to the baseline, The incidence of the composite endpoint of MACCEs such as death from all causes, cardiac death, hospitalization due to worsening / decompensation of HF, stroke / transient ischemic attack (TIA), acute coronary syndrome (ACS) , the need for a heart transplant (HT), the need for a left ventricular assist device (LVAD) or biventricular , an unplanned hospitalization or an outpatient visit due to the need to administer intravenous diuretics or requiring an increase in the dose of diuretics >50% base, Hospitalization

Countries

Poland

Outcome results

None listed

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