ClinicalTrials.gg
RecruitingNCT02638142DIUR-AHFUpdated Aug 8, 2025

Loop Diuretic Therapy in Acutely Decompensated Heart Failure

An observational study in Acute Heart Failure, sponsored by University of Siena. Recruiting at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by University of Siena · Observational

From the registry’s dates

  • Started Dec 2015; still recruiting 10 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
370
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Heart Failure

Keywords

  • loop diuretic
  • heart failure
  • renal dysfunction
  • congestion signs
  • BNP
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 370 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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; : Left Ventricular Ejection Fraction.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
370 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Continuous Furosemide Infusion

    continuous intravenous furosemide infusion

    Drug: Continuous Furosemide Infusion

  • Intermittent Furosemide Infusion

    bolus intermittent intravenous furosemide infusion

    Drug: Intermittent Furosemide Infusion

Interventions

  • DrugContinuous Furosemide Infusion

    Intravenous continuous Furosemide infusion

    Also known as: cIV

  • DrugIntermittent Furosemide Infusion

    Intravenous bolus intermittent Furosemide Infusion

    Also known as: iIV

06

What researchers measure

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)

  5. Body weight changes

    Body weight changes in two groups from the admission to discharge

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

  6. Diuresis

    mean urine output in two groups from the admission to discharge

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

  7. BNP changes

    mean paired changes of B-type natriuretic peptide (BNP) in the two groups during hospitalization.

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

  8. BUN changes

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

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

  9. Reduction of edema

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

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

  10. Reduction of dyspnea

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

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

  11. 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

    Time frame: From date of randomization

  12. 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.

    Time frame: From hospital admission until the discharge (7-12 days)

  13. 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.

    Time frame: 180 days

  14. 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.

    Time frame: 180 days

07

Study locations

4 of 4 sites recruiting
  • Ospedale Madonna della Navicella
    Chioggia, Venezia, Italy
    Recruiting
    • Roberto Valle, MD · Contact
    • Roberto Valle, MD · Principal investigator
  • Azienda Ospedaliera di Padova
    Padova, Italy
    Recruiting
    • Giorgio Vescovo, MD · Contact
    • Giorgio Vescovo, MD · Principal investigator
  • University of Rome La Sapienza
    Roma, 00189, Italy
    Recruiting
  • Department of Internal Medicine, Cardiovascular Diseases Unit
    Siena, 53100, Italy
    Recruiting
    • Alberto Palazzuoli, MD · Contactpalazzuoli2@unisi.it · +39577585363
    • Alberto Palazzuoli, MD · Principal investigator
    • Gaetano Ruocco, MD · Sub investigator
08

References and documents

Publications

  • 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 Care. 2014 Jun 28;18(3):R134. doi: 10.1186/cc13952. PubMed 24974232 ↗
  • 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 CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419. PubMed 21366472 ↗
  • 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 Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3. PubMed 26041600 ↗
  • 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. 2015 Aug;170(2):313-21. doi: 10.1016/j.ahj.2015.05.003. Epub 2015 May 9. PubMed 26299229 ↗
  • 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 and clinical outcome--an analysis from RELAX-AHF. Eur J Heart Fail. 2014 Nov;16(11):1230-40. doi: 10.1002/ejhf.170. Epub 2014 Oct 7. PubMed 25287144 ↗
  • Palazzuoli A, Dini FL, Pugliese NR, Ruocco G, Severino P, Vizza D, Carbonara R, Passantino A, Carluccio E. Right Ventricular-Pulmonary Artery Uncoupling and Strain in Acute Heart Failure. J Am Heart Assoc. 2025 May 6;14(9):e039858. doi: 10.1161/JAHA.124.039858. Epub 2025 May 2. PubMed 40314350 ↗
  • Palazzuoli A, Ruocco G, Vescovo G, Valle R, Di Somma S, Nuti R. Rationale and study design of intravenous loop diuretic administration in acute heart failure: DIUR-AHF. ESC Heart Fail. 2017 Nov;4(4):479-486. doi: 10.1002/ehf2.12226. Epub 2017 Oct 4. PubMed 28980452 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2015 (actual). Primary completion is estimated for Jan 2028, 145 months after the start.

Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 145 months is above that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2015
First posted
Dec 22, 2015
StartActual
Dec 2015
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Aug 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02638142
Lead sponsor
University of Siena
Collaborators
University of Roma La Sapienza, Ospedale Regina Montis Regalis, University of Naples, A.O.U. Città della Salute e della Scienza, University of Milan
Responsible party
Alberto Palazzuoli MD PhD (Medical Doctor, Cardiologist, University of Siena) — Principal investigator
First posted
Dec 22, 2015
Start date
Dec 2015
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 8, 2025

Study contacts

Alberto Palazzuoli, MD
Contact
palazzuoli2@unisi.it
+390577585363
Gaetano Ruocco, MD
Contact
gmruocco@virgilio.it
+393386577898
Alberto Palazzuoli, MD
principal investigator · University of Siena

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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