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SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure (SURE-HF)

2026年6月1日 更新者：Nurgul Ablakimova

Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)

The SURE-HF trial is a pragmatic, multicentre, randomized controlled study evaluating natriuresis-guided optimization of intravenous loop diuretic therapy in patients hospitalized with worsening heart failure (WHF). The study aims to determine whether serial urinary sodium assessment combined with a structured decongestive treatment algorithm improves decongestion, reduces the need for therapy escalation, and enhances discharge readiness compared with standard care.

Participants will be randomized to standard urine output-guided therapy or natriuresis-guided decongestive strategies using different intravenous loop diuretic administration regimens. The study integrates bedside diagnostic tools including lung ultrasound, inferior vena cava assessment, focused echocardiography, and serial clinical congestion monitoring.

The primary endpoint is a hierarchical composite outcome including escalation of heart failure therapy, persistent congestion at discharge, inability to transition to oral loop diuretics by Day 5, and residual ultrasound congestion. The findings of the SURE-HF trial may support implementation of urinary sodium-guided and ultrasound-assisted decongestive therapy in routine heart failure management.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

260

段階

  • 適用できない

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

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:

  • Age ≥18 years.
  • Confirmed diagnosis of worsening heart failure (WHF), characterized by symptoms and signs of acute decompensation requiring hospitalization for intensification of intravenous diuretic therapy.
  • Previous intake of a loop diuretic (torasemide or furosemide) in any dose for at least 2 days before hospitalization.
  • Presence of clinical signs and symptoms of congestion (e.g., dyspnea, orthopnea, peripheral edema, pulmonary congestion).
  • Provision of written informed consent.

Exclusion Criteria:

  • Acute coronary syndrome within the previous 30 days.
  • Acute heart failure requiring urgent invasive intervention, including cardiogenic shock or mechanical circulatory support.
  • Current admission to an intensive care unit.
  • Systolic blood pressure ≤90 mmHg or requirement for inotropic/vasopressor support.
  • Recent use (≤48 hours) of inotropic agents affecting fluid and electrolyte balance.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or requirement for renal replacement therapy.
  • Hypokalemia (<3.5 mmol/L) or hyperkalemia (≥5.5 mmol/L).
  • Clinically significant hyponatremia (<130 mmol/L) or hypernatremia (>150 mmol/L).
  • Significant comorbidities affecting sodium-water balance (e.g., liver cirrhosis with ascites, nephrotic syndrome, severe infection or sepsis).
  • Pregnancy or breastfeeding.
  • Active malignancy.
  • Inability to comply with the study protocol or participation in another interventional clinical trial.

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：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：Standard Treatment
Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols.
薬：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
実験的：Natriuresis-Guided Intermittent IV Bolus
Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment.
薬：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
デバイス：Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
実験的：Natriuresis-Guided Continuous Infusion
Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment.
薬：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
デバイス：Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
実験的：Natriuresis-Guided Prolonged Intermittent Infusion
Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment.
薬：Furosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
デバイス：Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.

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
Hierarchical Composite Endpoint of Unsuccessful Decongestion
時間枠：From randomization through hospital discharge, assessed up to 14 days.
  1. Escalation of heart failure therapy within the first 5 days of hospitalization.
  2. Persistent clinical congestion at hospital discharge, defined as the presence of at least two of the following: dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, or elevated jugular venous pressure.
  3. Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization.
  4. Residual ultrasound congestion at hospital discharge, defined as ≥1 zone with ≥3 B-lines (one positive zone) on each hemithorax using 8-zone scanning
From randomization through hospital discharge, assessed up to 14 days.

二次結果の測定

結果測定
メジャーの説明
時間枠
Total and Time-Specific Urinary Sodium Excretion
時間枠：6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Time to Clinical Decongestion
時間枠：From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
Time from initiation of intravenous loop diuretic therapy to achievement of clinical decongestion, defined as resolution of clinical signs and symptoms of congestion, including absence of dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, and elevated jugular venous pressure.
From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
Length of Hospital Stay
時間枠：From hospital admission to hospital discharge, assessed up to 30 days.
Duration of hospitalization measured as the number of days from hospital admission to hospital discharge.
From hospital admission to hospital discharge, assessed up to 30 days.
Death or Heart Failure Rehospitalization Within 30 Days After Discharge
時間枠：From hospital discharge through 30 days after discharge.
Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge.
From hospital discharge through 30 days after discharge.
Cumulative Urine Output
時間枠：From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Total urine output measured during hospitalization.
From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Proportion of Patients Achieving Predefined Natriuresis Targets
時間枠：Within 72 hours after initiation of intravenous loop diuretic therapy.
Proportion of patients achieving predefined urinary sodium excretion targets according to the study treatment algorithm during the first 72 hours of hospitalization.
Within 72 hours after initiation of intravenous loop diuretic therapy.

その他の成果指標

結果測定
メジャーの説明
時間枠
Incidence of Symptomatic Hypotension
時間枠：From randomization through hospital discharge, assessed up to 14 days.
Occurrence of symptomatic hypotension during hospitalization.
From randomization through hospital discharge, assessed up to 14 days.
Clinically Significant Electrolyte Disturbances
時間枠：From baseline through hospital discharge, assessed up to 14 days.
Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.
From baseline through hospital discharge, assessed up to 14 days.
All-Cause In-Hospital Mortality
時間枠：From randomization through hospital discharge, assessed up to 14 days.
Death from any cause occurring during hospitalization.
From randomization through hospital discharge, assessed up to 14 days.

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

Nurgul Ablakimova

協力者

I.M. Sechenov First Moscow State Medical University

捜査官

  • 主任研究者：Nurgul Ablakimova, PhD、West Kazakhstan Marat Ospanov Medical University
  • スタディディレクター：Vadim Medovchshikov, PhD、West Kazakhstan Marat Ospanov Medical University
  • 主任研究者：Anzhela Soloveva, candidate of medical sciences、I.M. Sechenov First Moscow State Medical University
  • スタディチェア：Svetlana Rachina, doctor of medical sciences、I.M. Sechenov First Moscow State Medical University
  • スタディチェア：Gaziza Smagulova, candidate of medical sciences、West Kazakhstan Marat Ospanov Medical University
  • 主任研究者：Ayagoz Meshitbayeva、West Kazakhstan Marat Ospanov Medical University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (推定)

2026年6月1日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月8日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 13/2-19-38-7
  • Order №13/2-19-38-7 (その他の助成金/資金番号：West Kazakhstan Marat Ospanov medical university)

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?

はい

IPD プランの説明

De-identified individual participant data underlying the reported results may be shared upon reasonable request to the corresponding author following publication of the primary study results, subject to institutional approval and applicable data protection regulations.

IPD 共有時間枠

De-identified individual participant data and supporting documents will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.

IPD 共有アクセス基準

Access to de-identified individual participant data and supporting documents will be provided to qualified researchers upon reasonable request to the corresponding author and after approval by the study investigators and participating institution. Data sharing will be limited to non-commercial scientific research purposes and subject to applicable ethical and data protection requirements.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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