Loop Diuretic Therapy in Acutely Decompensated Heart Failure

NCT ID: NCT02638142

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 370 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2028-01-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Continuous Furosemide Infusion

continuous intravenous furosemide infusion

Continuous Furosemide Infusion

Intervention Type: DRUG

Intravenous continuous Furosemide infusion

Intermittent Furosemide Infusion

bolus intermittent intravenous furosemide infusion

Intermittent Furosemide Infusion

Intervention Type: DRUG

Intravenous bolus intermittent Furosemide Infusion

Interventions

Continuous Furosemide Infusion

Intravenous continuous Furosemide infusion

Intervention Type: DRUG

Intermittent Furosemide Infusion

Intravenous bolus intermittent Furosemide Infusion

Intervention Type: DRUG

Other Intervention Names

cIV; iIV

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

Ospedale Regina Montis Regalis

OTHER

Sponsor Role: collaborator

University of Naples

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Alberto Palazzuoli MD PhD

Medical Doctor, Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Palazzuoli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Siena

Locations

Ospedale Madonna della Navicella

Chioggia, Venezia, Italy

Site Status: RECRUITING

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status: RECRUITING

University of Rome La Sapienza

Roma, , Italy

Site Status: RECRUITING

Department of Internal Medicine, Cardiovascular Diseases Unit

Siena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alberto Palazzuoli, MD

Role: CONTACT

palazzuoli2@unisi.it

+390577585363

Gaetano Ruocco, MD

Role: CONTACT

gmruocco@virgilio.it

+393386577898

Facility Contacts

Roberto Valle, MD

Role: primary

Giorgio Vescovo, MD

Role: primary

Salvatore Di Somma, MD

Role: primary

salvatore.disomma@uniroma1.it

+3906.33775581

Alberto Palazzuoli, MD

Role: primary

palazzuoli2@unisi.it

+39577585363

References

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.

Reference Type: RESULT

PMID: 24974232 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21366472 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26041600 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26299229 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25287144 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40314350 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28980452 (View on PubMed)

Other Identifiers

DIUR-AHF

Identifier Type: -

Identifier Source: org_study_id