Loop Diuretic Therapy in Acutely Decompensated Heart Failure

NCT02638142 | Recruiting DMC

• 1 other identifier: DIUR-AHF
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Heart Failure

Keywords

loop diuretic; heart failure; renal dysfunction; congestion signs; BNP

Outcome Measures

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.

  180 days

Secondary Outcomes (14)

• length of hospital stay (days)

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

• Inotropes agents

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

• hypertonic saline solution

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

• Acute kidney injury

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

• Body weight changes

  from admission to discharge (7-12 days)

Study Arms (2)

Continuous Furosemide Infusion

continuous intravenous furosemide infusion

Drug: Continuous Furosemide Infusion

Intermittent Furosemide Infusion

bolus intermittent intravenous furosemide infusion

Drug: Intermittent Furosemide Infusion

Interventions

Continuous Furosemide Infusion DRUG

Intravenous continuous Furosemide infusion

Also known as: cIV

Continuous Furosemide Infusion

Intermittent Furosemide Infusion DRUG

Intravenous bolus intermittent Furosemide Infusion

Also known as: iIV

Intermittent Furosemide Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead
• 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

Study Sites (4)

Ospedale Madonna della Navicella

Chioggia, Venezia, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, Italy

RECRUITING

University of Rome La Sapienza

Roma, 00189, Italy

RECRUITING

Department of Internal Medicine, Cardiovascular Diseases Unit

Siena, 53100, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 24974232 RESULT

• 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.

  PMID: 21366472 RESULT

• 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.

  PMID: 26041600 RESULT

• 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.

  PMID: 26299229 RESULT

• 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.

  PMID: 25287144 RESULT

• 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.

  PMID: 40314350 DERIVED

• 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.

  PMID: 28980452 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alberto Palazzuoli, MD

  University of Siena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Palazzuoli, MD

CONTACT

+390577585363; palazzuoli2@unisi.it

Gaetano Ruocco, MD

CONTACT

+393386577898; gmruocco@virgilio.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Cardiologist

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)