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| Name | Class |
|---|---|
| University of Roma La Sapienza | OTHER |
| Ospedale Regina Montis Regalis | OTHER |
| University of Naples | OTHER |
| A.O.U. Città della Salute e della Scienza |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Furosemide Infusion | continuous intravenous furosemide infusion |
| |
| Intermittent Furosemide Infusion | bolus intermittent intravenous furosemide infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Furosemide Infusion | Drug | Intravenous continuous Furosemide infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death and rehospitalization for HF | Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay (days) | evaluation of length of hospital stay (days) in the two groups | From date of randomization until the discharge (7-12 days) |
| Inotropes agents | Need to use inotropes agents during the treatment |
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Inclusion Criteria:
ADHF: Acute Decompensated Heart Failure; BNP: B-type Natriuretic Peptide; IV: IntraVenous; LVEF: Left Ventricular Ejection Fraction.
Exclusion Criteria:
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patients who met diagnostic criteria for ADHF, independently from systolic function by exhibiting: at least one symptom at rest between dyspnea, orthopnea, peripheral edema and major fatigue; and at least two clinical signs including rales, pulmonary congestion on chest radiography, jugular vein dilatation and a third heart sound. An elevation in blood BNP >100 pg/ml was considered supportive for a diagnosis of ADHF
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Palazzuoli, MD | Contact | +390577585363 | palazzuoli2@unisi.it | |
| Gaetano Ruocco, MD | Contact | +393386577898 | gmruocco@virgilio.it |
| Name | Affiliation | Role |
|---|---|---|
| Alberto Palazzuoli, MD | University of Siena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Madonna della Navicella | Recruiting | Chioggia | Venezia | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24974232 | Result | 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. | |
| 21366472 | Result |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| OTHER |
| University of Milan | OTHER |
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blood samples
| Intermittent Furosemide Infusion | Drug | Intravenous bolus intermittent Furosemide Infusion |
|
|
| From date of randomization until the discharge (7-12 days) |
| hypertonic saline solution | need to use hypertonic saline solution during the treatment | From date of randomization until the discharge (7-12 days) |
| Acute kidney injury | changes of renal function in terms of creatinine and estimated glomerular filtration rate (eGFR) comparing continuous vs intermittent administration | From date of randomization until the discharge (7-12 days) |
| Body weight changes | Body weight changes in two groups from the admission to discharge | from admission to discharge (7-12 days) |
| Diuresis | mean urine output in two groups from the admission to discharge | from admission to discharge (7-12 days) |
| BNP changes | mean paired changes of B-type natriuretic peptide (BNP) in the two groups during hospitalization. | From date of randomization until the discharge (7-12 days) |
| BUN changes | mean paired changes of blood urea nitrogen (BUN) in the two groups during hospitalization. | From date of randomization until the discharge (7-12 days) |
| Reduction of edema | Evaluation of edema regression (or not) after treatment in the two groups. | From date of randomization until the discharge (7-12 days) |
| Reduction of dyspnea | Evaluation of dyspnea scale reduction (or not) after treatment in the two groups. | From date of randomization until the discharge (7-12 days) |
| Regression of pulmonary congestion | Evaluation of pulmonary congestion regression (or not) after treatment in the two groups, considering Chest X-ray at admission and at discharge | From date of randomization |
| Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide) | Evaluation of persistence of congestion (or not) and incidence of AKI (or not) according to quartiles of diuretic efficiency. | From hospital admission until the discharge (7-12 days) |
| High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage | Number of patients with high in-hospital diuretic dosage who were affected by adverse outcome. | 180 days |
| Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide) | Number of patients (according quartiles of diuretic efficiency) who were affected by adverse outcome. | 180 days |
| Azienda Ospedaliera di Padova | Recruiting | Padova | Italy |
|
| University of Rome La Sapienza | Recruiting | Roma | 00189 | Italy |
|
| Department of Internal Medicine, Cardiovascular Diseases Unit | Recruiting | Siena | 53100 | Italy |
|
| 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 3;364(9):797-805. doi: 10.1056/NEJMoa1005419. |
| 26041600 | Result | 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 Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3. |
| 26299229 | Result | 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. |
| 25287144 | Result | 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. |
| 40314350 | Derived | 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. |
| 28980452 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |