Acute Heart Failure
Conditions
Keywords
loop diuretic, heart failure, renal dysfunction, congestion signs, BNP
Brief summary
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.
Detailed description
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.
Interventions
DRUGContinuous Furosemide Infusion
Intravenous continuous Furosemide infusion
DRUGIntermittent Furosemide Infusion
Intravenous bolus intermittent Furosemide Infusion
Sponsors
University of Roma La Sapienza
Ospedale Regina Montis Regalis
University of Naples
A.O.U. Città della Salute e della Scienza
University of Milan
University of Siena
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death and rehospitalization for HF | 180 days | Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inotropes agents | From date of randomization until the discharge (7-12 days) | Need to use inotropes agents during the treatment |
| hypertonic saline solution | From date of randomization until the discharge (7-12 days) | need to use hypertonic saline solution during the treatment |
| Acute kidney injury | From date of randomization until the discharge (7-12 days) | changes of renal function in terms of creatinine and estimated glomerular filtration rate (eGFR) comparing continuous vs intermittent administration |
| Body weight changes | from admission to discharge (7-12 days) | Body weight changes in two groups from the admission to discharge |
| Diuresis | from admission to discharge (7-12 days) | mean urine output in two groups from the admission to discharge |
| BNP changes | From date of randomization until the discharge (7-12 days) | mean paired changes of B-type natriuretic peptide (BNP) in the two groups during hospitalization. |
| length of hospital stay (days) | From date of randomization until the discharge (7-12 days) | evaluation of length of hospital stay (days) in the two groups |
| Reduction of edema | From date of randomization until the discharge (7-12 days) | Evaluation of edema regression (or not) after treatment in the two groups. |
| Reduction of dyspnea | From date of randomization until the discharge (7-12 days) | Evaluation of dyspnea scale reduction (or not) after treatment in the two groups. |
| Regression of pulmonary congestion | From date of randomization | Evaluation of pulmonary congestion regression (or not) after treatment in the two groups, considering Chest X-ray at admission and at discharge |
| Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide) | From hospital admission until the discharge (7-12 days) | Evaluation of persistence of congestion (or not) and incidence of AKI (or not) according to quartiles of diuretic efficiency. |
| High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage | 180 days | Number of patients with high in-hospital diuretic dosage who were affected by adverse outcome. |
| BUN changes | From date of randomization until the discharge (7-12 days) | mean paired changes of blood urea nitrogen (BUN) in the two groups during hospitalization. |
Countries
Italy
Contacts
Primary ContactAlberto Palazzuoli, MD
Backup ContactGaetano Ruocco, MD
Outcome results
None listed