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Loop Diuretic Therapy in Acutely Decompensated Heart Failure

ConditionAcute Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Siena

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Continuous Furosemide Infusion

    Drug

    Intravenous continuous Furosemide infusion

  • Intermittent Furosemide Infusion

    Drug

    Intravenous bolus intermittent Furosemide Infusion

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Continuous Furosemide Infusion1 intervention
Group B: Intermittent Furosemide Infusion1 intervention

Trial outcomes

Primary outcomes

1

Cardiac death and rehospitalization for HF

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

Time frame
180 days

Secondary outcomes

1

length of hospital stay (days)

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

Time frame
From date of randomization until the discharge (7-12 days)
2

Inotropes agents

Need to use inotropes agents during the treatment

Time frame
From date of randomization until the discharge (7-12 days)
3

hypertonic saline solution

need to use hypertonic saline solution during the treatment

Time frame
From date of randomization until the discharge (7-12 days)
4

Acute kidney injury

changes of renal function in terms of creatinine and estimated glomerular filtration rate (eGFR) comparing continuous vs intermittent administration

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Siena

Lead sponsor

University of Roma La Sapienza

Collaborator

Ospedale Regina Montis Regalis

Collaborator

University of Naples

Collaborator

A.O.U. Città della Salute e della Scienza

Collaborator

University of Milan

Collaborator

Source ClinicalTrials.gov
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