Acute Heart FailureDIUR-AHFNCT02638142
Loop Diuretic Therapy in Acutely Decompensated Heart Failure
An observational study of Acute Heart Failure, run by University of Siena at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Continuous Furosemide Infusion and Intermittent Furosemide Infusion
- Type of treatment
- Injection or infusion
- How many people
- 370 participants
- Where
- 4 sitesItaly
- Study dates
- Dec 2015to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Ospedale Madonna della Navicella
Chioggia, Venezia
Roberto Valle, MD
Roberto Valle, MD
- Recruiting
Azienda Ospedaliera di Padova
Padova
Giorgio Vescovo, MD
Giorgio Vescovo, MD
- Recruiting
University of Rome La Sapienza
Roma, 00189
Salvatore Di Somma, MD, +3906.33775581, salvatore.disomma@uniroma1.it
Salvatore Di Somma, MD
- Recruiting
Department of Internal Medicine, Cardiovascular Diseases Unit
Siena, 53100
Alberto Palazzuoli, MD, +39577585363, palazzuoli2@unisi.it
Alberto Palazzuoli, MD
About this study
Official title: 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.
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.
- Conditions
- Acute Heart Failure
- Being tested
- Continuous Furosemide Infusion, Intermittent Furosemide Infusion
- Keywords
- loop diuretic, heart failure, renal dysfunction, congestion signs, BNP
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Furosemide InfusionDrug
Also called cIV
Intravenous continuous Furosemide infusion
Intermittent Furosemide InfusionDrug
Also called iIV
Intravenous bolus intermittent Furosemide Infusion
| Study group | Role | What they receive |
|---|---|---|
| Continuous Furosemide Infusion | continuous intravenous furosemide infusion Receives: Drug: Continuous Furosemide Infusion | |
| Intermittent Furosemide Infusion | bolus intermittent intravenous furosemide infusion Receives: Drug: Intermittent Furosemide Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death and rehospitalization for HF
Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge.
Measured: 180 days
Secondary outcomes (14)
length of hospital stay (days)
evaluation of length of hospital stay (days) in the two groups
Measured: From date of randomization until the discharge (7-12 days)
Inotropes agents
Need to use inotropes agents during the treatment
Measured: From date of randomization until the discharge (7-12 days)
hypertonic saline solution
need to use hypertonic saline solution during the treatment
Measured: From date of randomization until the discharge (7-12 days)
Acute kidney injury
changes of renal function in terms of creatinine and estimated glomerular filtration rate (eGFR) comparing continuous vs intermittent administration
Measured: From date of randomization until the discharge (7-12 days)
Body weight changes
Body weight changes in two groups from the admission to discharge
Measured: from admission to discharge (7-12 days)
Diuresis
mean urine output in two groups from the admission to discharge
Measured: from admission to discharge (7-12 days)
BNP changes
mean paired changes of B-type natriuretic peptide (BNP) in the two groups during hospitalization.
Measured: From date of randomization until the discharge (7-12 days)
BUN changes
mean paired changes of blood urea nitrogen (BUN) in the two groups during hospitalization.
Measured: From date of randomization until the discharge (7-12 days)
Reduction of edema
Evaluation of edema regression (or not) after treatment in the two groups.
Measured: From date of randomization until the discharge (7-12 days)
Reduction of dyspnea
Evaluation of dyspnea scale reduction (or not) after treatment in the two groups.
Measured: From date of randomization until the discharge (7-12 days)
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
Measured: From date of randomization
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.
Measured: From hospital admission until the discharge (7-12 days)
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.
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Alberto Palazzuoli MD PhD, University of Siena
- Investigators
- Alberto Palazzuoli, MD, Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638142
- Sponsor's protocol ID
- DIUR-AHF
- Acronym
- DIUR-AHF
- Status last verified
- Aug 2025
- First submitted
- 9 Dec 2015
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 24974232Felker 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 21366472Lala 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 26041600ter 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 26299229Voors 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 25287144Palazzuoli 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 40314350Palazzuoli 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Bolus Intermittent Loop Diuretic Infusion in Acutely Decompensated Heart Failure: Evaluation of Renal Function, Congestion Signs, BNP and Outcome
- ClinicalTrials.gov ID
- NCT02638142
- Acronym / sponsor ID
- DIUR-AHF / DIUR-AHF
- Conditions
- Acute Heart Failure
- Keywords
- loop diuretic, heart failure, renal dysfunction, congestion signs, BNP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- 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
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Furosemide Infusion | – | Drug: Continuous Furosemide Infusioncontinuous intravenous furosemide infusion |
| Intermittent Furosemide Infusion | – | Drug: Intermittent Furosemide Infusionbolus intermittent intravenous furosemide infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Furosemide InfusionAlso: cIVIntravenous continuous Furosemide infusion | Drug | Continuous Furosemide Infusion |
| Intermittent Furosemide InfusionAlso: iIVIntravenous bolus intermittent Furosemide Infusion | Drug | Intermittent Furosemide Infusion |
Primary outcome
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.
14 secondary outcomes
length of hospital stay (days)
Time frame: From date of randomization until the discharge (7-12 days)
Inotropes agents
Time frame: 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)
Acute kidney injury
Time frame: From date of randomization until the discharge (7-12 days)
Body weight changes
Time frame: from admission to discharge (7-12 days)
Diuresis
Time frame: from admission to discharge (7-12 days)
BNP changes
Time frame: From date of randomization until the discharge (7-12 days)
BUN changes
Time frame: 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)
Reduction of dyspnea
Time frame: From date of randomization until the discharge (7-12 days)
Regression of pulmonary congestion
Time frame: 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)
High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage
Time frame: 180 days
Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide)
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Results publication: PubMed 24974232Palazzuoli 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.
- Results publication: PubMed 21366472Felker 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.
- Results publication: PubMed 26041600Lala 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.
- Results publication: PubMed 26299229ter 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.
- Results publication: PubMed 25287144Voors 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.
- Derived from this study: PubMed 40314350Palazzuoli 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.
- Derived from this study: PubMed 28980452Palazzuoli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto Palazzuoli, MD principal investigator
University of Siena
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by University of Siena at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Palazzuoli, MD (+390577585363, palazzuoli2@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death and rehospitalization for HF (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02638142, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.