Loop Diuretic Therapy in Acutely Decompensated Heart Failure

Официальное название

Continuous Versus Bolus Intermittent Loop Diuretic Infusion in Acutely Decompensated Heart Failure: Evaluation of Renal Function, Congestion Signs, BNP and Outcome

Обзор

DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.

Подробное описание

The use of intravenous loop diuretics is a cornerstone of therapy for acutely decompensated heart failure (ADHF); significant concerns have been raised regarding risks and benefits of loop diuretics, particularly about dosage and administration regimen.

Recent guidelines recommend the use of these drugs to reduce left ventricular filling pressure, avoid pulmonary edema, and alleviate peripheral fluid retention.

Some studies have provided guidelines for the administration of these drugs in clinical practice, but data interpretation remains challenging due to the frequent exclusion of patients with kidney disease from major ADHF clinical trials. Therefore, it is not clear if continuous infusion is better than intermittent boluses in terms of decongestion, maintenance of renal filtration function and prognosis.

On the other hand, continuous administration should provide a more constant delivery of the drug into the tubule, potentially reducing these phenomena.

The aim of the study is to evaluate the better loop diuretic intravenous administration in terms of renal function, congestion signs, BNP and outcome.

Вмешательства

• Препарат Continuous Furosemide Infusion
  Intravenous continuous Furosemide infusion
• Препарат Intermittent Furosemide Infusion
  Intravenous bolus intermittent Furosemide Infusion

Первичные конечные точки

• Cardiac death and rehospitalization for HF [Срок оценки: 180 days]

Вторичные конечные точки (12)

• length of hospital stay (days) [Срок оценки: From date of randomization until the discharge (7-12 days)]
• Inotropes agents [Срок оценки: From date of randomization until the discharge (7-12 days)]
• hypertonic saline solution [Срок оценки: From date of randomization until the discharge (7-12 days)]
• Acute kidney injury [Срок оценки: From date of randomization until the discharge (7-12 days)]
• Body weight changes [Срок оценки: from admission to discharge (7-12 days)]
• Diuresis [Срок оценки: from admission to discharge (7-12 days)]
• BNP changes [Срок оценки: From date of randomization until the discharge (7-12 days)]
• BUN changes [Срок оценки: From date of randomization until the discharge (7-12 days)]
• Reduction of edema [Срок оценки: From date of randomization until the discharge (7-12 days)]
• Reduction of dyspnea [Срок оценки: From date of randomization until the discharge (7-12 days)]
• Regression of pulmonary congestion [Срок оценки: From date of randomization]
• Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide) [Срок оценки: From hospital admission until the discharge (7-12 days)]

Критерии участия

Критерии включения

• Patients over 18 years;
• Patients with diagnosis of ADHF(dyspnea, orthopnea, peripheral edema or major fatigue and at least two clinical signs including rales, hepatomegaly, pulmonary congestion on chest radiography, jugular vein dilatation, or a third heart sound);
• Blood BNP > 100 pg/mL;

ADHF: Acute Decompensated Heart Failure; BNP: B-type Natriuretic Peptide; IV: IntraVenous; LVEF: Left Ventricular Ejection Fraction.

Критерии исключения

• Patients who receive more than 40 mg of IV furosemide;
• End-Stage renal disease or renal replacement therapy;
• Recent myocardial infarction (within thirty days of screening);
• Systolic blood pressure < 80 mmHg;
• Creatinine levels > 4 mg/dL;
• Patients affected by sepsis, liver diseases, inflammatory diseases or neoplastic diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 4 центра

• Ospedale Madonna della Navicella — Chioggia
• Azienda Ospedaliera di Padova — Padova
• University of Rome La Sapienza — Roma
• Department of Internal Medicine, Cardiovascular Diseases Unit — Siena

Публикации

• Palazzuoli A, Pellegrini M, Ruocco G, Martini G, Franci B, Campagna MS, Gilleman M, Nuti R, McCullough PA, Ronco C. Continuous versus bolus intermittent loop diuretic infusion in acutely decompensated heart failure: a prospective randomized trial. Crit Care. 2014 Jun 28;18(3):R134. doi: 10.1186/cc13952. PMID 24974232
• Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar PMID 21366472
• Lala A, McNulty SE, Mentz RJ, Dunlay SM, Vader JM, AbouEzzeddine OF, DeVore AD, Khazanie P, Redfield MM, Goldsmith SR, Bart BA, Anstrom KJ, Felker GM, Hernandez AF, Stevenson LW. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue PMID 26041600
• ter Maaten JM, Dunning AM, Valente MA, Damman K, Ezekowitz JA, Califf RM, Starling RC, van der Meer P, O'Connor CM, Schulte PJ, Testani JM, Hernandez AF, Tang WH, Voors AA. Diuretic response in acute heart failure-an analysis from ASCEND-HF. Am Heart J. 2015 Aug;170(2):313-21. doi: 10.1016/j.ahj.2015.05.003. Epub 2015 May 9. PMID 26299229
• Voors AA, Davison BA, Teerlink JR, Felker GM, Cotter G, Filippatos G, Greenberg BH, Pang PS, Levin B, Hua TA, Severin T, Ponikowski P, Metra M; RELAX-AHF Investigators. Diuretic response in patients with acute decompensated heart failure: characteristics and clinical outcome--an analysis from RELAX-AHF. Eur J Heart Fail. 2014 Nov;16(11):1230-40. doi: 10.1002/ejhf.170. Epub 2014 Oct 7. PMID 25287144
• Palazzuoli A, Dini FL, Pugliese NR, Ruocco G, Severino P, Vizza D, Carbonara R, Passantino A, Carluccio E. Right Ventricular-Pulmonary Artery Uncoupling and Strain in Acute Heart Failure. J Am Heart Assoc. 2025 May 6;14(9):e039858. doi: 10.1161/JAHA.124.039858. Epub 2025 May 2. PMID 40314350
• Palazzuoli A, Ruocco G, Vescovo G, Valle R, Di Somma S, Nuti R. Rationale and study design of intravenous loop diuretic administration in acute heart failure: DIUR-AHF. ESC Heart Fail. 2017 Nov;4(4):479-486. doi: 10.1002/ehf2.12226. Epub 2017 Oct 4. PMID 28980452

Идентификаторы

NCT: NCT02638142 · DIUR-AHF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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