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Loop Diuretic Therapy in Acutely Decompensated Heart Failure (DIUR-AHF)

U

University of Siena

Status

Enrolling

Conditions

Acute Heart Failure

Treatments

Drug: Intermittent Furosemide Infusion
Drug: Continuous Furosemide Infusion

Study type

Observational

Funder types

Other

Identifiers

NCT02638142
DIUR-AHF

Details and patient eligibility

About

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.

Full 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.

Enrollment

370 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

370 participants in 2 patient groups

Continuous Furosemide Infusion
Description:
continuous intravenous furosemide infusion
Treatment:
Drug: Continuous Furosemide Infusion
Intermittent Furosemide Infusion
Description:
bolus intermittent intravenous furosemide infusion
Treatment:
Drug: Intermittent Furosemide Infusion

Trial contacts and locations

4

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Central trial contact

Alberto Palazzuoli, MD; Gaetano Ruocco, MD

Data sourced from clinicaltrials.gov

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