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Effect of Sacubitril-Valsartan on Estimated Pulmonary Artery Systolic Pressure in Patients With Heart Failure With Reduced Ejection Fraction Heart Failure

5 de setembro de 2026 atualizado por: Mennatullah Nasser, Aswan University

Effect of (Sacubitril-Valsartan) Drug on Estimated Pulmonary Artery Systolic Pressure

Evaluate effect of Sacubitril-Valsartan on estimated pulmonary artery systolic pressure in patient with reduced ejection fraction heart failure

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Worldwide, the burden of heart failure has increased to an estimated 23 million people, and approximately 50% of cases are heart failure with reduced ejection fraction (HFrEF). Heart failure is a clinical syndrome characterized by dyspnea or exertional limitation due to impairment of ventricular filling or ejection of blood or both.

Heart failure with reduced ejection fraction HFrEF occurs when the left ventricular ejection fraction (LVEF) is 40% or less and is accompanied by progressive left ventricular dilatation and adverse cardiac remodeling. Assessment for heart failure begins with obtaining a medical history and physical examination. Also central to diagnosis are elevated natriuretic peptides above age- and context-specific thresholds and identification of left ventricular systolic dysfunction with LVEF of 40% or less as measured by echocardiography. Treatment strategies include the use of diuretics to relieve symptoms and application of an expanding armamentarium of disease-modifying drug and device therapies.

The Pulmonary hypertension definition has been changed recently to include mean Pulmonary artery pressure, 20 mm Hg, and Pulmonary vascular resistance, 2.0 WU, for distinguishing each of the hemodynamic Pulmonary hypertension subgroups: isolated precapillary, combined precapillary/postcapillary, and isolated postcapillary Pulmonary hypertension.

The goals of therapy of heart failure with reduced ejection fraction are to reduce morbidity (ie, reduce symptoms, improve health-related quality of life and functional status, and decrease the rate of hospitalization), and to reduce mortality.

Attempts to treat PH in HFpEF-PH have resulted in a succession of failures, despite approaching this problem from different pathobiological angles. The endothelin receptor antagonist bosentan, which is effective in pulmonary arterial hypertension, has failed in HFpEF-PH.3 The potent phosphodiesterase type 5 inhibitor sildenafil increases cyclic guanosine monophosphate (cGMP) levels, causing endogenous nitric oxide-mediated vasodilatation in both systemic and pulmonary vasculature. Despite the initial positive trial in the field reported by Guazzi et al., other attempts have failed to show a reduction in pulmonary artery pressure (PAP) or improvement in other haemodynamic parameters in HFpEF-PH. Increased cGMP levels by oral soluble guanylate cyclase stimulators also increase cGMP levels but do not affect PAP, pulmonary vascular resistance, or transpulmonary pressure gradient. Lastly, direct NO donors were examined in the INDIE-HFpEF (Inorganic Nitrite Delivery to Improve Exercise Capacity in Heart Failure with Preserved Ejection Fraction) trial but resulted in no benefit in terms of exercise capacity, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, New York Heart Association (NYHA) functional class, diastolic function, or N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

Management of heart failure with reduced ejection fraction HFrEF includes management of the cause of heart failure and associated conditions, monitoring, preventative care, care coordination, education and support for heart failure self-management (including lifestyle modification and daily monitoring), pharmacologic therapy, cardiac rehabilitation, palliative care, device therapy (including cardiac resynchronization therapy, implantable cardioverter defibrillator, and mechanical circulatory support [eg, LV assist device]) and cardiac transplantation .

The angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan (Sac/Val) is a particulate guanylyl cyclase activator that increases natriuretic peptides, which signal through cGMP and exert potent antimitogenic and vasodilatory effects.

Sacubitril/valsartan is the latest "disease-modifying drug" approved for the management of patients with heart failure with reduced ejection fraction (HFrEF) In addition to a reduction in the rate of mortality and hospitalization, both randomized clinical trials and real-life studies have shown that sacubitril/valsartan induced the "reverse remodeling" of the left ventricle (LV), with a reduction in the ventricular volumes, an increase in the ejection fraction (EF) [4,5], an improvement in the diastolic function and a reduction in the degree of functional mitral regurgitation.

In 2022 paper was published on the effect of Sacubitril/valsartan on pulmonary artery pressure in patients with heart failure with preserved function and shows these results Sacubitril/valsartan significantly reduced mean pulmonary artery pressure in patients with heart failure with preserved ejection fraction "HFpEF", independent of loop diuretic management, together with improvement in functional capacity, lung congestion, and quality of life. Sacubitril/valsartan may be a therapeutic alternative in HFpEF-PH .

In this study will be conducted to estimate the effect of (valsartan-sacubitril) on pulmonary artery systolic pressure in patient with HFrEF We will assume a research question which will be to what extent the use of (valsartan-sacubitril) does started from (50 mg bid to 200 mg bid) will cause reducing in pulmonary artery systolic pressure.

Tipo de estudo

Intervencional

Inscrição (Real)

59

Estágio

  • Fase 1

Contactos e Locais

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Locais de estudo

      • Aswān, Egito
        • Faculty of medicine- Aswan university

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Patients aged more than 18 years .
  • Diagnosed with HFrEF defined as those with an EF ≤40% .

Exclusion Criteria:

  • Patients < 18 years old

    • Patients with severe renal disease (i.e., estimated glomerular filtration rate according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ≤30 mL/min/1.73 m2),
    • Patients with moderate-severe liver disease (i.e., a Child-Pugh score ≥7),
    • Patients with severe chronic obstructive pulmonary disease (i.e., Global Initiative for ---Chronic Obstructive Lung Disease class ≥3), History of acute pulmonary embolism
    • History of prior heart surgery with pericardial incision.
    • Pregnancy and lactation.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: HFrEF patients on Sacubitril-Valsartan dose 24/26
Number of cases were 29 patients with reduced ejection fraction heart failure although being on 4 pillars of heart failure treatment " beta blockers, MRA, SGLT2 inhibitors and ACE inhibitor", replacement of ACEI with Sacubitril-Valsartan with dose 24mg/26mg was done with continuation on the same other anti-failure treatments
sacubitril-Valsartan is ARNI that is one of the pillars of heart failure treatment, here we study its effect on estimated pulmonary artery systolic pressure and studying its effect on relieving elevated pulmonary pressure symptoms.
Comparador Ativo: HFrEF patients on Sacubitril-Valsartan dose 49/51
Number of cases were 30 patients with reduced ejection fraction heart failure although being on 4 pillars of heart failure treatment " beta blockers, MRA, SGLT2 inhibitors and ACE inhibitor", replacement of ACEI with Sacubitril-Valsartan with dose 49mg/51mg was done with continuation on the same other anti-failure treatments
sacubitril-Valsartan is ARNI that is one of the pillars of heart failure treatment, here we study its effect on estimated pulmonary artery systolic pressure and studying its effect on relieving elevated pulmonary pressure symptoms.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Effect of Sacubitril-Valsartan on ePASP on patients with HFrEF
Prazo: 1 year
patients has been followed up by assessing echocardiography assessment of estimated PASP
1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
comparison of effect of doses of sacubitril valsartan on ePASP
Prazo: 1 year
compare of the effect of different doses of Sacubitril Valsartan 24/26 and 46/51 on estimated pulmonary artery systolic pressur
1 year

Colaboradores e Investigadores

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Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de julho de 2025

Conclusão Primária (Real)

5 de julho de 2026

Conclusão do estudo (Real)

12 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

12 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de setembro de 2026

Primeira postagem (Real)

11 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de setembro de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Sacubitril valsartan un PASP

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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