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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

2026年9月5日 更新者: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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

59

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Aswān、エジプト
        • Faculty of medicine- Aswan university

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Effect of Sacubitril-Valsartan on ePASP on patients with HFrEF
時間枠:1 year
patients has been followed up by assessing echocardiography assessment of estimated PASP
1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
comparison of effect of doses of sacubitril valsartan on ePASP
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年7月5日

一次修了 (実際)

2026年7月5日

研究の完了 (実際)

2026年7月12日

試験登録日

最初に提出

2026年7月12日

QC基準を満たした最初の提出物

2026年9月5日

最初の投稿 (実際)

2026年9月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月5日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Sacubitril valsartan un PASP

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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