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

April 18, 2019 updated by: Alberto Palazzuoli MD PhD, University of Siena

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Roma, Italy, 00189
        • University of Rome La Sapienza
      • Siena,, Italy, 53100
        • Department of Internal Medicine, Cardiovascular Diseases Unit
    • Venezia
      • Chioggia, Venezia, Italy
        • Ospedale Madonna della Navicella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Continuous Furosemide Infusion
continuous intravenous furosemide infusion
Drug: Continuous Furosemide Infusion
Intravenous continuous Furosemide infusion
Other Names:
  • cIV
Intermittent Furosemide Infusion
bolus intermittent intravenous furosemide infusion
Drug: Intermittent Furosemide Infusion
Intravenous bolus intermittent Furosemide Infusion
Other Names:
  • iIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the discharge (7-12 days)
Inotropes agents
Time Frame: From date of randomization until the discharge (7-12 days)
Need to use inotropes agents during the treatment
From date of randomization until the discharge (7-12 days)
hypertonic saline solution
Time Frame: From date of randomization until the discharge (7-12 days)
need to use hypertonic saline solution during the treatment
From date of randomization until the discharge (7-12 days)
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
From date of randomization until the discharge (7-12 days)
Body weight changes
Time Frame: from admission to discharge (7-12 days)
Body weight changes in two groups from the admission to discharge
from admission to discharge (7-12 days)
Diuresis
Time Frame: from admission to discharge (7-12 days)
mean urine output in two groups from the admission to discharge
from admission to discharge (7-12 days)
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.
From date of randomization until the discharge (7-12 days)
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.
From date of randomization until the discharge (7-12 days)
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.
From date of randomization until the discharge (7-12 days)
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.
From date of randomization until the discharge (7-12 days)
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
From date of randomization
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.
From hospital admission until the discharge (7-12 days)
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.
180 days
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.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Collaborators

University of Roma La Sapienza
Azienda Ospedaliera di Padova
Ospedale Madonna della Navicella

Investigators

  • Principal Investigator: Alberto Palazzuoli, MD, University of Siena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIUR-AHF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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