Loop Diuretic Therapy in Acutely Decompensated Heart Failure

Acute Heart Failure Clinical Trial

— DIUR-AHF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02638142
• Other study ID #: DIUR-AHF
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Continuous Furosemide Infusion
Intravenous continuous Furosemide infusion
• Intermittent Furosemide Infusion
Intravenous bolus intermittent Furosemide Infusion

Locations

Country	Name	City	State
Italy	Ospedale Madonna della Navicella	Chioggia	Venezia
Italy	Azienda Ospedaliera di Padova	Padova
Italy	University of Rome La Sapienza	Roma
Italy	Department of Internal Medicine, Cardiovascular Diseases Unit	Siena,

Sponsors (4)

Lead Sponsor	Collaborator
University of Siena	Azienda Ospedaliera di Padova, Ospedale Madonna della Navicella, University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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 — View Citation

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 Acu — View Citation

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 Ca — View Citation

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. 2 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death and rehospitalization for HF	Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge.	180 days
Secondary	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)
Secondary	Inotropes agents	Need to use inotropes agents during the treatment	From date of randomization until the discharge (7-12 days)
Secondary	hypertonic saline solution	need to use hypertonic saline solution during the treatment	From date of randomization until the discharge (7-12 days)
Secondary	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)
Secondary	Body weight changes	Body weight changes in two groups from the admission to discharge	from admission to discharge (7-12 days)
Secondary	Diuresis	mean urine output in two groups from the admission to discharge	from admission to discharge (7-12 days)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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