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Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)

2026年7月1日 更新者：University of Aarhus

Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)

Acute heart failure is a condition where the heart suddenly cannot pump blood well enough for the body's needs. Many people admitted to the hospital with acute heart failure have too much fluid in the body. This can cause shortness of breath, swelling, and the need for treatment with water-removing medicine.

Furosemide is a commonly used water-removing medicine that is given into a vein to treat fluid overload. It can be given in different ways. One way is as a continuous infusion, where the medicine is given slowly over time through a pump. Another way is as repeated injections given several times a day. It is not known whether one of these ways is better than the other for removing excess fluid in people with acute heart failure.

The purpose of this study is to compare two ways of giving furosemide into a vein: Continuous infusion started with an initial extra dose, and bolus injections given three times a day. About 436 adults admitted to hospitals in Denmark with acute heart failure and fluid overload will take part. Participants will be randomly assigned to one of the two treatment groups. This means that chance will decide which treatment method each participant receives.

The main thing the researchers will measure is how much body weight participants lose about 3 days after randomization. Weight loss is used as a measure of how much excess fluid has been removed.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

INFUSE-AHF is an investigator-initiated, multicentre, open-label, pragmatic, randomized clinical trial conducted at hospitals in Denmark. The trial compares two commonly used ways of administering intravenous furosemide in adults hospitalized with acute heart failure and volume overload: Continuous infusion preceded by a loading dose, and bolus injections administered three times a day.

The rationale for the trial is that intravenous loop diuretics are standard treatment for acute heart failure with volume overload, but the optimal method of administration remains uncertain. Previous evidence has not established whether continuous infusion or bolus injections are superior. In addition, continuous infusion without an initial loading dose may delay achievement of effective plasma concentrations. The INFUSE-AHF trial, therefore, specifically evaluates continuous infusion preceded by a loading dose compared with bolus injections three times a day.

The trial includes three phases. The inclusion phase starts when a potential participant is identified during hospitalization and ends when the first dose of trial treatment is administered. The treatment phase starts with the first administration of intravenous furosemide and continues until the last weight measurement on the morning of Day 4. The follow-up phase starts after the treatment phase and continues until 30 days after the first injection.

Participants are randomized in a 1:1 ratio to one of the two treatment strategies. In the continuous infusion group, an initial loading dose is administered immediately before the infusion is started. In the bolus group, furosemide is administered as bolus injections three times a day, and the first bolus includes an additional dose to mirror the loading dose strategy. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at admission using a predefined dosing algorithm. During the first part of the treatment period, doses are protocolized. On the morning of Day 3, the treating clinician may increase the dose, maintain the same dose, or stop intravenous treatment according to the protocol and the participant's clinical status.

Approximately 436 participants will be enrolled. The primary endpoint is net weight loss 3 days, equivalent to approximately 72 hours, after randomization. Secondary endpoints include net weight loss 2 days after randomization, change in dyspnea on a Visual Analog Scale 3 days after randomization, days alive out of hospital to Day 30, and length of hospital stay. Safety endpoints include acute kidney injury, severe electrolyte disturbances, incidents, and side effects.

研究の種類

介入

入学 (推定)

436

段階

  • フェーズ 4

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。

研究連絡先

研究場所

  • デンマーク
      • Randers、デンマーク、8930
        • 募集
        • Department of Medicine, Randers Regional Hospital
        • コンタクト：

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:

  • Clinical diagnosis of acute heart failure with volume overload
  • At least 1 sign of volume overload
  • Anticipated intravenous furosemide treatment for at least 3 days
  • Age 18 years or older

Exclusion Criteria:

  • Shock
  • Patient requiring treatment with inotropes or vasopressors
  • Current or planned use of renal replacement therapy or ultrafiltration
  • Patient with a renal transplant
  • Patients who are pregnant or breastfeeding
  • Severe hypokalaemia, defined as potassium less than 2.5 mmol/L, or severe hyponatremia, defined as sodium less than 125 mmol/L
  • Allergy to furosemide and its components

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
実験的：Continuous infusion preceded by a loading dose
Participants receive intravenous furosemide administered as a continuous infusion preceded by an initial loading dose. The loading dose is administered immediately before initiation of the infusion. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
薬：Intravenous furosemide continuous infusion
Intravenous furosemide administered as a continuous infusion preceded by a loading dose. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
他の名前：
  • Furosemide infusion
実験的：Bolus injections three times a day
Participants receive intravenous furosemide administered as bolus injections three times a day. The first bolus injection includes an additional dose to mirror the loading dose strategy used in the continuous infusion group. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
薬：Intravenous furosemide bolus injections
Intravenous furosemide administered as bolus injections three times a day. The first bolus injection includes an additional dose to mirror the loading dose strategy used in the continuous infusion group. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
他の名前：
  • Furosemide bolus injections

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
Net weight loss 3 days after randomization
時間枠：From randomization to approximately 72 hours
Net change in body weight from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
From randomization to approximately 72 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Net weight loss 2 days after randomization
時間枠：From randomization to approximately 48 hours
Net change in body weight from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
From randomization to approximately 48 hours
Change in dyspnea 3 days after randomization
時間枠：From randomization to approximately 72 hours
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
From randomization to approximately 72 hours
Days alive out of hospital to Day 30
時間枠：From randomization to 30 days
Number of days alive and out of hospital from randomization to Day 30.
From randomization to 30 days
Length of hospital stay
時間枠：From randomization up to 30 days
Duration of the index hospital admission.
From randomization up to 30 days

その他の成果指標

結果測定
メジャーの説明
時間枠
Net weight loss 1 day after randomization
時間枠：From randomization to approximately 24 hours
Net change in body weight from randomization to the morning of Day 2, corresponding to approximately 24 hours after randomization.
From randomization to approximately 24 hours
Change in dyspnea 1 day after randomization
時間枠：From randomization to approximately 24 hours
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 2, corresponding to approximately 24 hours after randomization.
From randomization to approximately 24 hours
Change in dyspnea 2 days after randomization
時間枠：From randomization to approximately 48 hours
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
From randomization to approximately 48 hours
Death from any cause after 30 days
時間枠：From randomization to 30 days
All-cause mortality assessed 30 days after randomization.
From randomization to 30 days
Rehospitalization from any cause after 30 days
時間枠：From randomization to 30 days
Rehospitalization from any cause assessed 30 days after randomization.
From randomization to 30 days
Acute kidney injury
時間枠：From randomization to approximately 72 hours
Proportion of participants with acute kidney injury grade 2 or higher as defined by KDIGO criteria during the treatment phase.
From randomization to approximately 72 hours
Severe electrolyte disturbances
時間枠：From randomization to approximately 72 hours
Proportion of participants with severe hypokalaemia, severe hyponatremia, or severe hypernatremia, defined as potassium less than 2.5 mmol/L, sodium less than 125 mmol/L, or sodium greater than 155 mmol/L.
From randomization to approximately 72 hours
Incidents and side effects
時間枠：From randomization to 30 days
Treatment-emergent serious adverse events, including incidents and side effects.
From randomization to 30 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

University of Aarhus

協力者

Central Denmark Region

捜査官

  • スタディディレクター：Esben Merrild, MD、Department of Medicine, Randers Regional Hospital
  • スタディチェア：Bo Løfgren, MD PhD、Department of Medicine, Randers Regional Hospital
  • スタディチェア：Henrik Birn, MD PhD DMSc、Department of Renal Medicine, Aarhus University Hospital
  • スタディチェア：Kasper G Lauridsen, MD PhD、Department of Medicine, Randers Regional Hospital
  • スタディチェア：Christian B Poulsen, MD PhD、Private Organization

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。

便利なリンク

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)

2026年6月30日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年7月1日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • INFUSEAHF
  • 2025-523589-26-00 (Ctis)

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 may be made available after publication of the main trial results, subject to approval by the Steering Committee and in accordance with applicable data protection legislation. All trial data will be pseudo-anonymized and stored for 25 years after the end of the trial in accordance with Danish law and GDPR requirements. Data sharing will be considered on a case-by-case basis for scientifically sound research proposals that do not conflict with ongoing or planned analyses, intellectual property considerations, or the governance and objectives of the trial. Requests for data access must be submitted to the Scientific Lead or Coordinating Investigator and will be evaluated by the Steering Committee based on methodological quality, feasibility, and compatibility with the scientific, ethical, and strategic framework of the trial. There is no obligation for unrestricted, automatic, or indefinite data sharing.

IPD 共有時間枠

After publication of the main trial results. Data will be considered available on a case-by-case basis, and there is no predefined end date for availability.

IPD 共有アクセス基準

Requests must be submitted to the Scientific Lead or Coordinating Investigator and will be evaluated by the Steering Committee. Access may be granted for scientifically sound research proposals that do not conflict with ongoing or planned analyses, intellectual property considerations, or the governance and objectives of the trial. Requests will be evaluated based on methodological quality, feasibility, and compatibility with the scientific, ethical, and strategic framework of the trial.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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