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NCT Number: NCT02638142

Loop Diuretic Therapy in Acutely Decompensated Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Madonna della Navicella, Chioggia, Venezia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Furosemide Infusion

Drug

Intravenous continuous Furosemide infusion

Other names: cIV

Intermittent Furosemide Infusion

Drug

Intravenous bolus intermittent Furosemide Infusion

Other names: iIV

Primary outcomes

  1. Cardiac death and rehospitalization for HF

    Time frame: 180 days

    Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge.

Secondary outcomes

  1. length of hospital stay (days)

    Time frame: From date of randomization until the discharge (7-12 days)

    evaluation of length of hospital stay (days) in the two groups

  2. Inotropes agents

    Time frame: From date of randomization until the discharge (7-12 days)

    Need to use inotropes agents during the treatment

  3. hypertonic saline solution

    Time frame: From date of randomization until the discharge (7-12 days)

    need to use hypertonic saline solution during the treatment

  4. Acute kidney injury

    Time frame: 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

  5. Body weight changes

    Time frame: from admission to discharge (7-12 days)

    Body weight changes in two groups from the admission to discharge

  6. Diuresis

    Time frame: from admission to discharge (7-12 days)

    mean urine output in two groups from the admission to discharge

  7. BNP changes

    Time frame: 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.

  8. BUN changes

    Time frame: From date of randomization until the discharge (7-12 days)

    mean paired changes of blood urea nitrogen (BUN) in the two groups during hospitalization.

  9. Reduction of edema

    Time frame: From date of randomization until the discharge (7-12 days)

    Evaluation of edema regression (or not) after treatment in the two groups.

  10. Reduction of dyspnea

    Time frame: From date of randomization until the discharge (7-12 days)

    Evaluation of dyspnea scale reduction (or not) after treatment in the two groups.

  11. Regression of pulmonary congestion

    Time frame: 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

  12. Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide)

    Time frame: 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.

  13. High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage

    Time frame: 180 days

    Number of patients with high in-hospital diuretic dosage who were affected by adverse outcome.

  14. Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide)

    Time frame: 180 days

    Number of patients (according quartiles of diuretic efficiency) who were affected by adverse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Palazzuoli, MD

CONTACT

[email protected]

+390577585363

Gaetano Ruocco, MD

CONTACT

[email protected]

+393386577898

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza
  • Ospedale Regina Montis Regalis
  • University of Milan
  • University of Naples
  • University of Roma La Sapienza

Registry information

Official study title

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

Acronym: DIUR-AHF

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Dec 22, 2015
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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